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)

Eb-Series

blood uric acid control solution: one vial

Single (Specified) Analyte Controls (Assayed And Unassayed)

EasyGluco™G2 Meter Kit

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)

Accu-Sed® Plus Normal ESR Control Kit, 5×8.5ml

Catalogue number DS-71002, listed by ELITechGroup 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)

Advia Centaur® FSH MCM

The ADVIA Centaur FSH Master Curve Material verifies calibration and the reportable range of the ADVIA Centaur follicle-stimulating hormone assay. It is a prescription in-vitro diagnostic…

Single (Specified) Analyte Controls (Assayed And Unassayed)

HbA1C Control

HbA1c Control is a laboratory quality control material used to check the performance of HbA1c testing on clinical chemistry systems. Laboratories measure the control using the quantitative…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems FSH Calibration Verification Material FSH

FSH CVM - Immulite - Cons

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys CalCheck FT 3

Catalogue number 3554538190, 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)

On Call Vivid Glucose Control Solution Kit

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

uTASWako DCP Control H

2 catalogue numbers from 991-61401, listed by Fujifilm Wako Pure Chemical Corporation, 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 AFP MCM

Alpha-Fetoprotein(AFP) - Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Serum Control

Serum Control Level II, ß-Carotene in serum/plasma

Single (Specified) Analyte Controls (Assayed And Unassayed)

Accutrend Cholesterol Controls

Catalogue number 5219957001, 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)

AimStrip Tandem Total Triglycerides Control Solution

Lipid measuring meter and Triglycerides test strip control solution level 1,2

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite Systems High Sensitivity CRP CVM

CRP (High Sensitivity) CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems HPG Calibration Verification Material H. Pylori IgG

H. Pylori CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM BNP MCM

BNP Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® MYO MCM

Myoglobin Master Curve Material Set - CENTAUR - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

IDS High Sensitive Estradiol Control Set

For In Vitro Diagnostic Use. For Laboratory Professional Use. The IDS High Sensitive Estradiol Control Set is for in vitro diagnostic use, for the quality control of the IDS High Sensitive…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM NT-Pbnpii (Pbnpii)

PBNPII - ATELLICA IM - MCM Set

Single (Specified) Analyte Controls (Assayed And Unassayed)

Acrometrix HCV Low Control

Catalogue number 963001, 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)

Immulite® Systems SBG Calibration Verification Material Shbg

Shbg CVM - Immulite - Cons

Single (Specified) Analyte Controls (Assayed And Unassayed)

CalCheck IGF-1

Catalogue number 07475993190, 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)

UASure II Uric Acid Control Solution L1

Level 1

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys Anti-TPO CalCheck

Catalogue number 11820923190, 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 IgM Control Pack for Use on the Spaplus®

Catalogue number NQ012.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)

Accu-Sed® Plus Norm & Abn ESR Control Kit, 2×8.5ml

Catalogue number DS-71004, listed by ELITechGroup 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)

Quanta Flash® MPO Controls

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

Easy Talk

Easy Talk Blood Glucose Monitoring System(Meter Only Kit)

Single (Specified) Analyte Controls (Assayed And Unassayed)

High Sensitivity CRP Control – Level I (hsCRP Control 1)

Randox High Sensitivity CRP Control Level I 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)

Advia Centaur® Systems CAL Calibrator B

Total HCG B (6PK) (US) - CENTAUR - CAL - 6x2x5mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Osom H. Pylori Control Kit

Catalogue number 176, listed by Sekisui Diagnostics, LLC, 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)

Immulite® Systems TPI Calibration Verification Material Troponin I

Troponin I CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Acrometrix AntiHBs

Catalogue number 960855, 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)

Liaison® Control HSV-2 IgG

Catalogue number 310621, listed by Diasorin 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)

IgD AMR Fluid

Catalogue number BP506, 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 tIgE MCM

Total IgE (tIgE) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Diazyme

5 catalogue numbers from DZ042A-CON, listed by Diazyme Laboratories, 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)

Atellica IM Dig MCM

Digoxin (Dig) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems BR-MA Calibration Verification Material

BR-MA - Immulite - Cons

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM aCCP MCM

anti-CCP IgG (aCCP) Atellica IM - Master Curve Material 5 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Freelite Lambda Free Panel Sample Set

Catalogue number BP234, 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)

Precichek AutoCode AC302

PRECICHEK AutoCode AC302 Blood Glucose Monitoring System.

Single (Specified) Analyte Controls (Assayed And Unassayed)

B.r.a.h.m.s CgA II Kryptor QC

Catalogue number 083992N, listed by B.r.a.h.m.s 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)

AMH Control Level 1 (AMH Control 1)

The AMH Control Level 1 (AMH10509) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Ideal Life Blood Glucose Test Strips 1 Vial of 25 Test Strips

Test Strips a vial of 25 Test Strips

Single (Specified) Analyte Controls (Assayed And Unassayed)

Carolina Liquid Chemistries Corp.® HCY Level 2 Control KIT Part# CC052

HCY (Homocysteine) Level 2 control 6 x 5 mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

BD Veritor System Group a Strep Control Swab Set

10 ea. Group A Strep (-) Control Swabs, 10 ea. Group A Strep (+) Control Swabs

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM Cyfra 21-1 MCM

CYFRA 21-1 (CYFRA) Atellica IM - Master Curve Material

Single (Specified) Analyte Controls (Assayed And Unassayed)

Quanta Flash® β2GPI IgM Controls

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

Alere NT-proBNP for Alinity Control Kit

The Alere NT-proBNP for Alinity i Controls are for the estimation of test precision and the detection of systematic analytical deviations of the Alinity i analyzer when used for the…

Single (Specified) Analyte Controls (Assayed And Unassayed)

DImension Vista® C1 Inhibitor Control

C1IN CON is an assayed, mid level, intralaboratory quality control for the assessment of precision and analytical bias in the determination of the C1IN method on the Dimension Vista® System

Single (Specified) Analyte Controls (Assayed And Unassayed)

GlucoTrack Solution Level 1

Catalogue number GT-C01, 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)

AIA-Pack PAP Calibration Verification Test SET

AIA-Pack PAP 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)

Immulite® Systems OV Calibration Verification Material OM-MA (CA 125)

CA 125 CVM - Immulite - Cons

Single (Specified) Analyte Controls (Assayed And Unassayed)

B.r.a.h.m.s PlGF Plus Kryptor QC

Catalogue number 085992N, listed by B.r.a.h.m.s 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)

Advia Centaur® PTH

Intact parathyroid hormone Master Curve Material (iPTH MCM) Set - 7x1 mL - 7 Levels.

Single (Specified) Analyte Controls (Assayed And Unassayed)

BNP Controls FOR Beckman (BNP Control)

The BNP Controls for Beckman (CQ10520) are intended for use with in vitro diagnostic assays for the quantitative determination of BNP in human serum and plasma. The BNP Controls for Beckman…

Single (Specified) Analyte Controls (Assayed And Unassayed)

On Call Express Blood Glucose Monitoring System

Catalogue number G115-10D, listed by Acon Laboratories, 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)

GL GoodLife Glucose Control Solution(Level 1)

GL GoodLife Glucose Control Solution(Level 1) for use with GL GoodLife Blood Glucose System

Single (Specified) Analyte Controls (Assayed And Unassayed)

Rosie SmartMeter Glucose Control Solutions

Rosie SmartMeter glucose control solution

Single (Specified) Analyte Controls (Assayed And Unassayed)

Microdot® Pro Control Solution

Catalogue number 400-02, listed by Cambridge Sensors USA, LLC., 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® IgA Control Pack

Catalogue number NQ010.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)

Quanta Flash® aCL IgM Controls

1. QUANTA Flash aCL IgM Low Control 3 x 1 mL barcoded tubes of a solution with aCL IgM in saline solution containing fetal bovine serum stabilizers and preservative. 2. QUANTA Flash aCL IgM…

Single (Specified) Analyte Controls (Assayed And Unassayed)

TRUEcontrol

TRUEcontrol Solution Level 2

Single (Specified) Analyte Controls (Assayed And Unassayed)

Optilite® Albumin Control Pack

Catalogue number NQ032.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)

Immulite® 2000 TSI CVM

Immulite(R) 2000 TSI CVM

Single (Specified) Analyte Controls (Assayed And Unassayed)

Siemens Healthineers Cyfra 21-1 MCM

CYFRA 21-1 (CYFRA) Siemens Healthineers - Master Curve Material

Single (Specified) Analyte Controls (Assayed And Unassayed)

Tenovi

Tenovi Cellular Glucometer Control Solution

Single (Specified) Analyte Controls (Assayed And Unassayed)

Contour® Next

Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of diabetes. This kit contains the following items: CONTOUR® Next Blood Glucose Meter; 10 CONTOUR® NEXT…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Optilite® IgG3 Control Pack

Catalogue number NQ008.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)

Optilite® Rheumatoid Factor Control Pack

Catalogue number NQ151.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)

Embrace Pro Control Solution (L1/Normal; L2/High)

Catalogue number ALL02AB0210, listed by Omnis Health, 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)

ReliOn Ultima

Relion Utlima Blood Glucose Monitoring System

Single (Specified) Analyte Controls (Assayed And Unassayed)

Quanta Flash® DGP Screen Controls

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

Assure® Control – Control Solution Level 3

Catalogue number 510007, listed by Arkray USA, 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)

K-Assay® Total IgE Control

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

Gojji Glucose Control Soln-Normal

Gojji Glucose Control Soln-Normal: 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)

IDS-iSYS Total Testosterone Control Set

The IDS-iSYS Total Testosterone Control Set is for in vitro diagnostic use, for the quality control of the IDS-iSYS Total Testosterone on the IDS System.

Single (Specified) Analyte Controls (Assayed And Unassayed)

IDS Acth II Control Set

Catalogue number IS-4530NG, 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)

Assure® Control – Control Solution Level 2

Catalogue number 510005, listed by Arkray USA, 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)

PreciControl Syphilis

Syphilis PC Elecsys

Single (Specified) Analyte Controls (Assayed And Unassayed)

HemosIL Homocysteine Controls

Catalogue number 00020007900, 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)

Advia Centaur® CEA MCM

CEA Master Curve Material Set - CENTAUR - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Liquid Glycated Haemoglobin (HbA1c) Control Level 2 (LIQ HbA1c Control Level 2)

This product is intended for in vitro diagnostic use, in the quality control of the accuracy of Glycated Haemoglobin (HbA1c) on clinical chemistry systems.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Sweat Controls, L1, L2, L3, 12 Ea., 36×0.75ml

ELITechGroup Sweat Controls for Cystic Fibrosis Testing are assayed controls intended as a means of validating the measurement of conductivity , osmolality, or chloride in patient samples.

Single (Specified) Analyte Controls (Assayed And Unassayed)

PreciControl CMV IgG

Catalogue number 4784600160, 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)

Freelite® Human Kappa Free Control Pack for Use on the Roche Cobas Integra®

5 catalogue numbers from NQ016.CB, 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 CA 125II MCM

CA 125II - Atellica IM - Master Curve Material Kit 8 x 1 x 1.0 mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Parathyroid Hormone Control – Level 3 (PTH Control 3)

Catalogue number PTH10112, 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)

Advia Centaur TSH3ULII MCM SET

TSH3-ULII ADVIA Centaur - Consumable MCM Set

Single (Specified) Analyte Controls (Assayed And Unassayed)

K-Assay® RF / ASO Liquid Control

2 catalogue numbers from K125C-2M, listed by Kamiya Biomedical Company LLC, 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)

Atellica IM VitD QC

Vitamin D total 25(OH) (VitD) QC Kit Atellica IM - CLT 2 x 3 x 2.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Control Kit – PSA

Two levels of controls for the following assays: TPSA, FPSA FPSA is not available in the US.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM Tstii MCM

Testoterone II (TSTII) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys Folate III CalCheck

Catalogue number 5219086160, 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)

Advia Centaur® VitD MCM

Vitamin D Master Curve Material Set - CENTAUR - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Prodigy Voice Blood Glucose Monitoring System

Prodigy Voice Blood Glucose Monitoring System (KIT)

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys CalCheck T-Uptake

Catalogue number 11776657160, 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 Myoglobin CalCheck 5

Catalogue number 6270069160, 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)

Vigil

Vigil HbA1c Controls Levels 1 & 2

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® aCCP IgG MCM

Anti-CCP IgG (aCCP) MCM

Single (Specified) Analyte Controls (Assayed And Unassayed)

Glycerol Control (GLY Control)

Catalogue number GY1369, 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)

ACE Elevated Control

Catalogue number SC-131EL, listed by Analytical Control Systems, 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)

Advia Centaur® FER MCM

Ferritin Master Curve Material Set - CENTAUR - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

TSH CalCheck 5

Catalogue number 05917824160, 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)

Pylo Health

Pylo Control Solution

Single (Specified) Analyte Controls (Assayed And Unassayed)

Frend Testosterone Linearity Kit

FREND™ Testosterone Linearity Kit is intended for use as an assayed linearity material for the testosterone on the FREND™ System. The Linearity Kit is for the FREND™ System only. FREND™…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems HCY Calibration Verification Material Homocysteine

Homocysteine CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Nova Lite® IFA Yo (PCA-1) Positive Control

1 x 0.5mL Yo (PCA-1) Positive Control

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® Calibrator B

Total HCG B (6PK) (Ref) - CENTAUR - CAL - 6x2x5mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Accu-Chek Smart View

Accu-Chek Smart View Control 6/CS

Single (Specified) Analyte Controls (Assayed And Unassayed)

HemosIL AcuStar Anti-Cardiolipin IgM Controls

Catalogue number 0009802108, 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)

Freelite® Human Lambda Free Control Pack for Use on the Siemens Bn™ii

4 catalogue numbers from NQ018.T, 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)

In Touch Glucose Control Solution

In Touch Control solution with 1 bottle high, 1 bottle low

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys FT4 CalCheck

Catalogue number 11776665160, 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)

Axis-Shield Homocysteine Controls

The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of total L-homocysteine in human serum or…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Aldolase Level 2 Control (ALS Control 2)

Catalogue number AD5001, 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)

Yumizen C1200 C02 Control

Catalogue number 1300023950, listed by Horiba ABX SAS, 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)

AccuTrak

AccuTrak T-Uptake Calibration Verification Panel

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys Anti-Tg CalCheck

Catalogue number 3149056122, 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