Single (Specified) Analyte Controls (Assayed and Unassayed)

Who Makes This Device Type in China?

12 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Zhejiang and Beijing, and 4 other provinces. 3 of them are contract manufacturers, able to build to a buyer’s own specification.

Acon Biotech (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
BD Rapid Diagnostics (Suzhou) Co., Ltd.
Beijing Genesee Biotech, Inc. Beijing
Changsha Sinocare Inc. Hunan
Dirui Industrial Co., Ltd. Jilin, contract manufacturer
Flextronics Industrial (Shenzhen) Co., Ltd. Guangdong, contract manufacturer
Guangdong Transtek Medical Electronics Co., Ltd. Guangdong, contract manufacturer
Human Metabolomics Institute, Inc. Guangdong
Sejoy Biomedical Co., Ltd. Zhejiang
Tianjin Empecs Medical Device Co., Ltd. Tianjin, contract manufacturer
Vivachek Biotech (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
Yasee Biomedical Inc Shandong, contract manufacturer

How Is JJX Classified?

Single (Specified) Analyte Controls (Assayed And Unassayed) is FDA product code JJX, Class 1, 21 CFR 862.1660.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 42 recalls under this product code since 2006. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (6), Device Design (4) and Storage (3).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Access sTfR QC2 and QC3

The Access sTfR QC2 and QC3 is intended for monitoring system performance of the Access sTfR assay.

Single (Specified) Analyte Controls (Assayed And Unassayed)

IDS-iSYS 25 VitDS Control Set

2 catalogue numbers from IS-2530N, listed by Immunodiagnostic Systems Ltd., United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Oh’Care Lite

Glucose Control Solution Level 2

Single (Specified) Analyte Controls (Assayed And Unassayed)

ROM Plus® Quality Control Kit

ROM Plus®, Quality Control for Fetal Membranes Rupture Test

Single (Specified) Analyte Controls (Assayed And Unassayed)

Active Vitamin B12 Control Level 2

The Active Vitamin B12 Control Level 2 is intended for use with in vitro diagnostic assays for the quantitative determination of active Vitamin B12 (Holotranscobalamin/HoloTC) in human…

Single (Specified) Analyte Controls (Assayed And Unassayed)

McKesson

Control KIT, Preg HCG (1/BX)

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite Systems Beta-2 Microglobulin CVM

Beta-2 Microglobulin CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Mycoplama Genitalium IVT Wild Type Control

In vitro transcript of Mycoplasma genitalium 23S RNA

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM aTPO MCM

TPO Ab - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys IgE CalCheck 5

Catalogue number 5918022160, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Optilite® C4 Control Pack

Catalogue number NQ025.OPT, listed by The Binding Site Group Ltd., United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

HbA1c Quality Control Kit Level 1

HbA1c Quality Control Kit Level 1 for use with EasyRA Analyzer

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® FOL MCM

Folic Acid Master Curve Material - CENTAUR - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM aTgII Master Curve Material (aTgII MCM)

Atellica IM aTgII Master Curve Material

Single (Specified) Analyte Controls (Assayed And Unassayed)

Oh’Care Lite Glucose Control Solution

Glucose Control Solution

Single (Specified) Analyte Controls (Assayed And Unassayed)

Acrometrix EV Low Control

Catalogue number 960501, listed by Microgenics Corporation, United States, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

A1c-Cellular Linearity

A1c-Cellular Linearity contains one vial each of Levels 1-5. A1c-Cellular Linearity assesses the accuracy and linear reportable range of the HbA1c parameter.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys Progesterone III CalCheck 5

Catalogue number 7092555190, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Cystatin C Control Set Gen.2

Catalogue number 6729371190, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

PreciControl Anti-HCV

Catalogue number 03290379190, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Cystatin C Control – Level 2 (Cysc Control 2)

The Cystatin C Control is intended for use with in vitro diagnostic assays for the quantitative determination of Cystatin C. Cystatin C Control is assayed with target values and it is…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Dimension Vista® / Dimension® EXL™ Lctni CON L

LOCI Cardiac Troponin-I Control (low), 12 vials x2.2mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Fructosamine (Fruc)

Catalogue number FR4030, listed by Randox Laboratories Limited, United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Access Hybritech p2PSA QC

The Access Hybritech p2PSA QC are tri-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of [-2]proPSA isoform of…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Quanta Flash® β2GPI IgA Controls

1. QUANTA Flash ß2GP1 IgA Low Control: 3 x 1 mL barcoded tubes of a solution with anti- ß2GP1 IgA in phosphate buffer, containing bovine serum albumin, stabilizers and preservative. 2.…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Homocysteine Control Kit

Catalogue number 5142423190, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Human IgG Control Pack for Use on the Spaplus®

Catalogue number NQ004.S, listed by The Binding Site Group Ltd., United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

DriDye 405

Catalogue number 405, listed by Awareness Technology, Inc., United States, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

HemosIL AcuStar Anti-Cardiolipin IgG Controls

Catalogue number 0009802104, listed by Instrumentation Laboratory SPA, Italy, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Livongo Control Solution

Livongo Control Solution with 1 bottle high / 1 bottle low

Single (Specified) Analyte Controls (Assayed And Unassayed)

Human C4 Control Pack for Use on the Spaplus®

Catalogue number NQ025.S, listed by The Binding Site Group Ltd., United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Ammonia Alcohol Control Level 2 Set 3x5ml

Catalogue number 1312-31, listed by Quantimetrix Corp., United States, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Acrometrix HBV High Control

Catalogue number 965003, listed by Microgenics Corporation, United States, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys beta-CrossLaps CalCheck

Catalogue number 3140652122, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys PCT CalCheck 5

Catalogue number 05915686190, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Nova Lite® IFA Pancreatic Islet Cell Positive Control

1 x 0.5mL Pancreatic Islet Cell Pos. Ctl.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems MYO Calibration Verification Material Myoglobin

Myoglobin CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Optilite® Prealbumin Control Pack

Catalogue number NQ066.OPT, listed by The Binding Site Group Ltd., United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Trinity Biotech

Bile Acids Controls

Single (Specified) Analyte Controls (Assayed And Unassayed)

Precichek AutoCode Foil Packed Test Strip

PRECICHEK AutoCode Blood Glucose ACH foil packed test strip

Single (Specified) Analyte Controls (Assayed And Unassayed)

Β-Hydroxybutyrate 21 Bi-Level Controls

For use as controls in quantative procedures for β-Hydroxybutyrate

Single (Specified) Analyte Controls (Assayed And Unassayed)

PreciControl HbA1c Path

Catalogue number 5912504190, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

AFP CalCheck

Catalogue number 11776614190, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite 2000 Systems Anti-CCP IgG Calibration Verification Material

IMMULITE® 2000 Systems CCP Calibration Verification Material Anti-CCP IgG

Single (Specified) Analyte Controls (Assayed And Unassayed)

Quanta Flash® B2GP1-Domain1 Controls

1. QUANTA Flash ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. 2. QUANTA…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Oh’Care Lite Smart Glucose Control Solution-Level 1

blood glucose meter and test strip control solution level 1

Single (Specified) Analyte Controls (Assayed And Unassayed)

MAS SARS-CoV-2 Negative Control

Catalogue number 10028306, listed by Microgenics Corporation, United States, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Optilite® Caeruloplasmin Control Pack

Catalogue number NQ045.OPT, listed by The Binding Site Group Ltd., United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM Thyroglobulin (Tg)

Atellica IM Thyroglobulin (Tg) MCM Set

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems GAS Calibration Verification Material Gastrin

Gastrin CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® Systems, ACS 180® Systems AFP MCM

Alpha-Fetoprotein (AFP) Master Curve Material Kit

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® Shbg MCM Set

ADVIA Centaur Sex Hormone Binding Globulin Master Curve Material (SHBG MCM) Set - 5x1mL - 5 Levels

Single (Specified) Analyte Controls (Assayed And Unassayed)

Human Beta-2 Microglobulin Control Pack for Use on the Spaplus®

Catalogue number NQ043.S, listed by The Binding Site Group Ltd., United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Carolina Liquid Chemistries Corp. Basic Multi-Drug Control Set

CREA (Creatinine)

Single (Specified) Analyte Controls (Assayed And Unassayed)

PreciControl Release Syphilis

Catalogue number 09366903190, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

IDS Cortisol Control Set

Catalogue number IS-4630, listed by Immunodiagnostic Systems Ltd., United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

On Call Pro Glucose Control Solution Kit

Glucose Control Solution Kit includes 2mL Control 0, 2mL Control 1, 2mL Control 2

Single (Specified) Analyte Controls (Assayed And Unassayed)

Gojji Ketone Control SOLUTION-L1

Gojji Ketone Control SOLUTION-L1: 1 catalogue number listed by Gojji, Inc., under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

AccuPlex™ SARS-CoV-2 Molecular Controls Kit

AccuPlex™ SARS-CoV-2 Molecular Controls kit (Positive and Negative member-5 X 1.5 ml)

Single (Specified) Analyte Controls (Assayed And Unassayed)

PreciControl Toxo IgG

Catalogue number 4618823160, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

BioTel Care® Double Control Solution

Double Control Solution for use with BioTel Care® Blood Glucose Meter and Test Strips.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Frend TSH Linearity Kit

FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Diska NuLife

2 catalogue numbers from DNL-VGC01, listed by Diska LLC, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Kroger Healthpro

Kroger Blood Glucose Control Solution

Single (Specified) Analyte Controls (Assayed And Unassayed)

Quanta Flash® Jo-1 Controls

1. QUANTA Flash Jo-1 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Jo-1 in the buffer, stabilizers, and…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Optilite® Freelite® Kappa Free Control Pack

Catalogue number NQ016.OPT, listed by The Binding Site Group Ltd., United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

K-Assay® Fructosamine Control

For use as a consistent test sample of known concentration for monitoring assay conditions for fructosamine.

Single (Specified) Analyte Controls (Assayed And Unassayed)

IDS Beta CrossLaps® (CTX-I) Control Set

Catalogue number IS-3030N, listed by Immunodiagnostic Systems Ltd., United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM Calibrator B

Calibrator B - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Perfect 3

Perfect 3 Blood Glucose Test Strip 1.Part Number:BY8818G0NL4 2.Packing Materials No.:BL8818PEA

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur Calcitonin MCM

Calcitonin (CALCT) ADVIA Centaur - Master Curve Material Kit 5 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

DriDye 492

Catalogue number 492, listed by Awareness Technology, Inc., United States, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

HealthPro

Healthpro Control Solution

Single (Specified) Analyte Controls (Assayed And Unassayed)

Health Wealth Safe

Catalogue number TCS01, listed by MIO Labs Inc., United States, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers

Catalogue number IS-3035, listed by Immunodiagnostic Systems Ltd., United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Complete D 25-OH Vitamin Control Level 1&2 Set 4x3ml

Complete D 25-OH Vitamin D Control is a laboratory quality control material for assays that quantify total 25-hydroxyvitamin D. Laboratories measure it alongside their testing procedures…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Glycated Serum Protein Linearity Set

Stanbio Glycated Serum Protein (GSP) Linearity Set is intended to be used for quality control procedures in verifying the linearity throughout the reportable range of Stanbio’s Glycated…

Single (Specified) Analyte Controls (Assayed And Unassayed)

ExtendSURE

The lypholised Hemoglobin A1c Linearity controls are prepared from human blood and contain normal hemoglobin, preservatives and stabilizers. The controls are formulated to give enhanced…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur Tnih MCM

ADVIA Centaur TNIH Master Curve Material Kit 5 x 1.0 mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Ketone Serum Controls

Ketone Serum Controls are intended for use with Ketone tablet tests. These controls are for professional use.

Single (Specified) Analyte Controls (Assayed And Unassayed)

AIA-Pack bHCG Calibration Verification Test Set

AIA-Pack bHCG Calibration Verification Test Set: 1 catalogue number listed by Tosoh Corp., Japan, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

GL GoodLife Glucose Control Solutions

GL GoodLife Glucose Control Solution

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® iPTH QC Ref

PTH intact - CENTAUR - CTL - 2 pack (REF)

Single (Specified) Analyte Controls (Assayed And Unassayed)

EasyGluco™ High Control Solution

Catalogue number IGM-0008, listed by U. S. Diagnostics, Inc., United States, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Hemoglobin A1c Control Set

Hemoglobin A1c Control Set: 1 catalogue number listed by Tosoh Corp., Japan, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Pip Control Solution Normal

Catalogue number PC002-US, listed by Philosys, Inc., United States, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Nova

StatStrip StatStrip Xpress GLU Control Level 1

Single (Specified) Analyte Controls (Assayed And Unassayed)

IDS-iSYS Intact PTH Control Set

Catalogue number IS-3230, listed by Immunodiagnostic Systems Ltd., United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys Rubella IgG CalCheck 5

Catalogue number 5917832160, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM CA 15-3 MCM

CA 15-3 Atellica IM Master Curve Material Kit 7 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Quanta Flash® GBM Controls

1. QUANTA Flash GBM Negative Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to GBM, prediluted, ready to use, 0.5mL (containing buffer, protein…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems ATG Calibration Verification Material Anti-TG Ab

TG Ab CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur Herpes-2 IgG Quality Control

Herpes-2 IgG (HSV2) ADVIA Centaur - Quality Control

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM Tumor Marker Quality Control (TM QC)

Tumor Marker - Atellica IM - Quality Control

Single (Specified) Analyte Controls (Assayed And Unassayed)

High Sensitivity CRP Control – Level II (hsCRP Control 2)

Randox High Sensitivity CRP Control Level II is a ready to use control in a stabilised protein base. It is intended for use with the Randox High Sensitivity CRP Assay (Catalogue No. CP3885)…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Molecular Mass Control (5)

Catalogue number 4781, listed by Sebia, France, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems TSH Control Third Generation TSH

TSH 3rd Gen - IMMULITE - CONS - 2x2.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® IgE MCM

ADVIA Centaur IgE Master Curve Material verifies the calibration and reportable range of the ADVIA Centaur Total IgE assay. It is an in vitro diagnostic laboratory material used with ADVIA…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys hGH CalCheck 5

Catalogue number 5942357160, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Dropper Spinal Fluid Control Level 1&2 Set 2x3ml

Catalogue number 1450-01, listed by Quantimetrix Corp., United States, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Fructosamine Calibrator

Catalogue number R85321, listed by Cliniqa Corporation, United States, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Dako

Cystatin C Calibrator

Single (Specified) Analyte Controls (Assayed And Unassayed)

Pip

Glucose Control Solutions L1(Low) and L2 (High) - 2 Vials 2.5mL each

Single (Specified) Analyte Controls (Assayed And Unassayed)

VivaGuard Ino

VivaGuard Ino Control Solution (L, M, H, 1 bottle/each)

Single (Specified) Analyte Controls (Assayed And Unassayed)

Alinity

Alinity c Cannabinoids Control 2 Kit

Single (Specified) Analyte Controls (Assayed And Unassayed)

Liquid CRP Control – Level 3 (CRP Control 3)

This product is intended for in vitro diagnostic use, in the quality control of CRP on clinical chemistry systems.

Single (Specified) Analyte Controls (Assayed And Unassayed)

DriDye 405/ 450

Catalogue number 405/ 450, listed by Awareness Technology, Inc., United States, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Fort Worth Diagnostics

Influenza A H5N1 Control 1E5 cp/mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

K-Assay® Beta-2 Microglobulin Urine Control

For use as a consistent test sample of known concentration for monitoring assay conditions for beta-2 microglobulin.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Total PSA CalCheck

Catalogue number 11776762160, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Antistreptolysin O AMR Fluid

Catalogue number BP529, listed by The Binding Site Group Ltd., United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

IDS-iSYS 17-OH Progesterone Control Set

The IDS-iSYS 17-OH Progesterone Control Set monitors the quality of the matching 17-OH Progesterone assay on the IDS-iSYS Multi-Discipline Automated System. It is intended for prescription…

Single (Specified) Analyte Controls (Assayed And Unassayed)

TruePoint

TruePoint Control Solution Low 4mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Mycoplasma Genitalium Macrolide Resistance IVT A2059C Control

In vitro transcript of Mycoplama genitalium 23S RNA including A 2059C mutation

Single (Specified) Analyte Controls (Assayed And Unassayed)

Oh’Care Lite Blood Glucose Monitoring System Kit

Blood Glucose Monitoring System Kit

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur Androstenedione MCM

Androstenedione (Andro) ADVIA Centaur - Master Curve Material 5x1x1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

IDS-iSYS Direct Renin Control Set

Catalogue number IS-4830, listed by Immunodiagnostic Systems Ltd., United Kingdom, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Quanta Flash® DGP IgA Controls

1. QUANTA Flash DGP IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Lipase NG OC Ctrl 1

Lipase NG OC CTRL 1 must be used only to verify the performance of the Lipase NG. Use the Control Material like the specimens, according to the indicated analytical procedure.

Single (Specified) Analyte Controls (Assayed And Unassayed)

PreciControl Beta-Amyloid (1-42) II

Catalogue number 08821968190, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer