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)

Acrometrix HIV-1 Low Control

Catalogue number 964001, 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)

Alere Triage®

Alere Triage® BNP QC Controls

Single (Specified) Analyte Controls (Assayed And Unassayed)

IgG SC AMR Set

Catalogue number BP504, 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® Systems T4 Calibration Verification Material Total T4

Total T4 CVM - Immulite - Cons

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM aTgII Quality Control (aTgII QC)

Atellica IM aTgII Quality Control Material

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems PEP Calibration Verification Material C-Peptide

C-Peptide CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM CA 19-9 MCM

CA 19-9 Atellica IM - Master Curve Material Kit 8 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Optilite® IgG4 Control Pack

Catalogue number NQ009.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)

Oracle

Oracle Blood Glucose Test Strip(BY8818G0NL4)

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® TSH3-UL MCM

TSH3-UL Master Curve Material Set - CENTAUR - CAL

Single (Specified) Analyte Controls (Assayed And Unassayed)

LTA Check Test Kit

Catalogue number 107117, listed by Bio/Data 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)

UniStrip Control Solution Low

UniStrip Control Solution Low 4mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur AMH QC Kit

Anti-Mullerian Hormone (AMH) - Centaur - Quality Control Kit - 3 x 2 x 2.0 mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Access Ostase QC

The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems VB Calibration Verification Material Vitamin B12

Vitamin B12 CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

PreciControl TS

Catalogue number 06445918160, 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)

Direct (HDL/LDL) Cholesterol Calibrator

For the Calibration of Stanbio HDL Cholesterol and LDL Cholesterol LiquiColor® Reagent Kits.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Mission Plus Hemoglobin (Hb) Control Solution Kit

2mL bottles of Level 0, Level 1, Level 2

Single (Specified) Analyte Controls (Assayed And Unassayed)

AIA-Pack PA Calibration Verification Test SET

AIA-Pack PA 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)

MedTest DX HCG Control Set

HCG Control Set, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Cenmed

CenMed hCG Serum Control NEGATIVE, 5mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

AimStrip Tandem Total Cholesterol Control Solution

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

B.r.a.h.m.s Sflt-1 Kryptor LIN

Catalogue number 084593N, 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)

Aldolase Level 3 Control (ALS Control 3)

Catalogue number AD5002, 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)

DriDye 450

Catalogue number 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)

Precichek AutoCode Vial Packed Test Strip

PRECICHEK AutoCode Blood Glucose ACH vial packed test strip.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Ransel Control

This product is intended for in vitro diagnostic use in the control of the Randox Ransel assay.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Yumizen C1200 L1 Cystatin C Control

Catalogue number 1300023951, 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)

CalSet PTH

Catalogue number 08928452190, 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)

Glycomark

Controls 1,5-anhydroglucitol (1,5-AG) Enzymatic 1,5-AG Assay for Glycemic Control

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys Cyfra 21-1 CalCheck 5

Elecsys CYFRA 21-1 CalCheck 5 is an assayed control material for checking calibration and the established measuring range of the Elecsys CYFRA 21-1 assay. It is used with the indicated…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems PTS Calibration Verification Material PSA

PSA CVM - Immulite – Cons

Single (Specified) Analyte Controls (Assayed And Unassayed)

Quanta Flash® Calprotectin Controls

1. QUANTA Flash Calprotectin Low Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain recombinant calprotectin with stabilizers and…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys CK-MB CalCheck 5

Catalogue number 5906024160, 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)

Alkaline Phosphatase Isoenzyme Control (1 X 1 Ml)

Catalogue number 5139, listed by Helena Laboratories, 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)

Immulite® Systems PRG Calibration Verification Material Progesterone

Progesterone CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® Ee2 MCM

Enhanced Estradiol 2 Master Curve Material Set - CENTAUR - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Optilite® Freelite® Lambda Free Control Pack

Catalogue number NQ018.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)

BD Veritor™ System RSV Control Swab Set

RSV Swabs Veritor System 10 Test

Single (Specified) Analyte Controls (Assayed And Unassayed)

Eurotrol GlucoTrol-NG

Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Nova MAX

Nova Max Glucose Normal Glucose Control Solution

Single (Specified) Analyte Controls (Assayed And Unassayed)

Precichek AC300

PRECICHEK AC300 Blood Glucose Monitoring System.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems PAP Calibration Verification Material PAP

PAP CVM - Immulite - Cons

Single (Specified) Analyte Controls (Assayed And Unassayed)

FastPack® IP Shbg

30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls

Single (Specified) Analyte Controls (Assayed And Unassayed)

ABX Pentra CO2 Control

Catalogue number 1220001650, 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)

Atellica IM Dheas MCM

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems E2 Calibration Verification Material Estradiol

Estradiol CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

PTH Control Level 2 (PTH Control 2)

The PTH Control Level 2 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyroid Hormone in human serum and plasma. The PTH Control Level…

Single (Specified) Analyte Controls (Assayed And Unassayed)

IDS-iSYS 25-Hydroxy Vitamin DS Calibration Verifiers

Catalogue number IS-2735S, 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)

Hepro.us MM1000 Blood Glucose Monitoring System Kit

Glucose Meter Kit: 1 meter, 1 lancing device, 1 carrying bag, 10 pcs sterile lancets, 1 logbook, 1 user manual

Single (Specified) Analyte Controls (Assayed And Unassayed)

i-STAT

i-STAT total B-hCG Control Level 3

Single (Specified) Analyte Controls (Assayed And Unassayed)

Human IgA Control Pack for Use on the Spaplus®

Catalogue number NQ010.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)

Optilite® Beta-2 Microglobulin Urine Control Pack

Catalogue number NQ043.L.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)

Frend Vitamin D 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)

Advia Centaur aTPOII QC

aTPOII ADVIA Centaur - CTL 2 x 3 x 1.0 mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Blood Glucose Control Solution

Blood Glucose Control Solution is intended for use with EKF Diagnostic’s Blood Glucose Test Strip. It is used to check that the meter and test strips are working together properly. It is…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Parathyroid Hormone Control – Level 2 (PTH Control 2)

Catalogue number PTH10111, 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)

Atellica IM Ee2 MCM

Enhanced Estradiol (eE2) Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Acrometrix HCV High Control

Catalogue number 963003, 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)

DRI THC 60 Ng/ml Urine Control

2 catalogue numbers from 1402, 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)

Rheumatoid Factor Linearity Verifiers (For Roche Systems) (Rflv)

Rheumatoid Factor Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Rheumatoid Factor (RF).

Single (Specified) Analyte Controls (Assayed And Unassayed)

Quanta Flash® RNP Controls

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

A1CNow+ Controls™ Levels 1+2

The A1CNow+ Controls™ are supplied in two levels as a frozen, ready-to-use material that requires no reconstitution. The control consists of human whole blood modified to target levels with…

Single (Specified) Analyte Controls (Assayed And Unassayed)

EasyTouch

EasyTouch GNP Hi/Lo Control Solution

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys Toxo IgG CalCheck 5

Catalogue number 5979650160, 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® Systems PTH Calibration Verification Material Intact PTH

PTH Intact CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys Insulin CalCheck 5

Catalogue number 5917891160, 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)

CalCheck Phospho-Tau (181p)

Catalogue number 07546424190, 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® H2n MCM

HER-2/NEU Master Curve Material - CENTAUR - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Access Syphilis QC

The Access Syphilis QC is intended for monitoring system performance of the Access Syphilis assay. The Access Syphilis QC is for use on Access Immunoassay Systems.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Minicap Hb A1c

Measure HbA1c from whole blood using a Capillary instrument

Single (Specified) Analyte Controls (Assayed And Unassayed)

Carolina Liquid Chemistries Corp.® CLC720 Vitamin D RGT KIT Product No. ST500

Vitamin D-direct control 2 x 2 mL (2 lev)

Single (Specified) Analyte Controls (Assayed And Unassayed)

B2M AMR Fluid

Catalogue number BP507, 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)

Mycoplasma Genitamium Macrolide Resistance IVT a 2059g Control

In vitro transcript of mycoplasma genitalium 23S RNA including A2059G mutation

Single (Specified) Analyte Controls (Assayed And Unassayed)

Cystatin C Control Set

Catalogue number X0973, listed by Agilent Technologies Singapore (International) Pte Ltd., Singapore, 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 Calibration Verifiers

The IDS-iSYS Total Testosterone Calibration Verifiers are an in vitro diagnostic device intended for medical purposes in the quantitative verification of assay calibration and measuring…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Dimension Vista® / Dimension® EXL™ Lctni CON H

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

ReliOn™ Premier Voice Basic Meter

The ReliOn Premier Voice Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and…

Single (Specified) Analyte Controls (Assayed And Unassayed)

BLE Smart® Control Solution

Control Solution Box 3 Pack

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM Herpes-2 IgG Quality Control

Herpes-2 IgG (HSV2) Atellica IM - Quality Control

Single (Specified) Analyte Controls (Assayed And Unassayed)

In Touch Glucose Control Solutions

Box of High/Low Control Solution

Single (Specified) Analyte Controls (Assayed And Unassayed)

Vitamin D Total II CalCheck 5

Catalogue number 07464258190, 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)

Acrometrix HIV-1 High Control

Catalogue number 964003, 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 CAL Calibration Verification Material Calcitonin

Calcitonin CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

B.r.a.h.m.s Sflt-1 Kryptor QC

Catalogue number 084592N, 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)

Panther Fusion®

Panther Fusion® Internal Control-B.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Dimension® Flex Reagent Cartridge HB1C

Hemoglobin B1c Flex® reagent cartridges, HB1C Calibrator

Single (Specified) Analyte Controls (Assayed And Unassayed)

MAS Cardioimmune Ultra Low

Catalogue number CAI-UL, 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)

Tg II CalCheck 5

Catalogue number 05918081190, 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 High Sensitive Estradiol Calibrator Set

For In Vitro Diagnostic Use. For Laboratory Professional Use. The IDS High Sensitive Estradiol Calibrator Set is used for the calibration of the IDS High Sensitive Estradiol on the IDS…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Easy Talk Control Solution – High

Blood glucose control solution for use with Easy Talk blood glucose testing system

Single (Specified) Analyte Controls (Assayed And Unassayed)

Glycated Serum Protein Bi-Level Control Set

Stanbio Glycated Serum Protein (GSP) Control Kit is intended to be used for quality control procedures in examining the accuracy and precision of Stanbio Glycated Serum Protein LiquiColor®…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur EPO Quality Control

Erythropoietin (EPO) QC Kit - ADVIA Centaur - CLT 3 x 3 x 7.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

GlucoTrack Solution Level 2

Catalogue number GT-C02, 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)

Quanta Flash® SS-B Controls

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

GlucoTrack Solution Level 3

Catalogue number GT-C03, 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)

Exacta Glance

Control Solutions Level 1 US

Single (Specified) Analyte Controls (Assayed And Unassayed)

Alere Afinion HbA1c Control

HbA1c Contols for use with the Alere Afinion HbA1c test and Afinion HbA1c test. Content: 1 Control C1. 1 Control C II. 1 package insert. DI covers Alere Afinion HbA1c Control and Afinion…

Single (Specified) Analyte Controls (Assayed And Unassayed)

RPD Control Solution

Catalogue number TCS01, listed by Remote Patient Devices 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)

Elecsys proBNP II CalCheck 5

Catalogue number 5913268160, 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® aCCP IgG QC

aCCP Control Set - CENTAUR - - CENTAUR - CTL - 1x2x7mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

IDS-iSYS Aldosterone Control Set

Catalogue number IS-3330, 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)

Immulite® Systems ATA Calibration Verification Material Anti-TPO Ab

Anti-TPO CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

High Sensitivity C-Reactive Protein Linearity Verifiers (For Roche Series)

High Sensitivity C-Reactive Protein Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche systems for High Sensitivity C-reactive protein (hsCRP).

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM EPO MCM

Erythropoietin (EPO) - Atellica IM - Master Curve Material Kit 5 x 1 x 1mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

IDS Estradiol Calibrator Set

For In Vitro Diagnostic Use For Laboratory Professional Use The IDS Estradiol Calibrator Set is used for the calibration of IDS Estradiol on the IDS system

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® Calibrator A

Thyroid (6PK) (Ref) - CENTAUR - CAL - 6x2x5mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM Brahms PCT QC Kit

Procalcitonin (PCT) QC Kit Atellica IM - CLT 2 x 2 x 2.0mL/vial

Single (Specified) Analyte Controls (Assayed And Unassayed)

MedTest DX HCG Control Set Level A

HCG Control Set Level A, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is…

Single (Specified) Analyte Controls (Assayed And Unassayed)

PreciControl Toxo IgM

Catalogue number 04618866190, 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)

Quidel Molecular

QMol Trichomonas Control Set

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM Calcitonin MCM

Calcitonin (CALCT) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

ACE Control

ACE Control is intended to be used with ACE Reagent to monitor the accuracy and precision of the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Capi 3 Hb A1c

Device intended for measurement of HbA1c in whole blood using capillary electrophoresis

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® TnI-Ultra MCM

Troponin I Ultra Master Curve Material Set - CENTAUR - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM ELF MCM SET

Catalogue number 11208708, listed by Siemens Healthcare 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)

Embrace Talk Control Solution L1 (LO)

Catalogue number APX03AB0318, 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)

On Call Express 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)

Advia Centaur® VB12 MCM

Vitamin B12 - Master Curve Material Set - CENTAUR - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM aTG MCM

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

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