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)

Immulite® Systems DPD Calibration Verification Material Pyrilinks-D

Pyrilinks-D CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

IDS-iSYS Human Growth Hormone (hGH) Calibration Verifiers

Catalogue number IS-3735, 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)

Advia Centaur® Dhea-S MCM

DHEA-S Master Curve Material Set - CENTAUR - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Liquid Glycated Haemoglobin (HbA1c) Control Set (LIQ HbA1c Control)

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)

Elecsys CalCheck Testosterone

Catalogue number 11776860160, 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)

True Metrix

ProCure TRUE METRIX Control Solution box includes 3mL Control level 1, 3mL Control level 3

Single (Specified) Analyte Controls (Assayed And Unassayed)

CareLiving MM1100 Control Solution for Blood Glucose

CareLiving MM1100 Control Solution

Single (Specified) Analyte Controls (Assayed And Unassayed)

Architect

Quantia B2-Microglobulin Calibrator

Single (Specified) Analyte Controls (Assayed And Unassayed)

Liquichek

Liquichek Diabetes Control Level Trilevel MiniPak (A human whole blood assayed diabetes control.)

Single (Specified) Analyte Controls (Assayed And Unassayed)

Vitamin D Control

2 catalogue numbers from 2130166, listed by Fujirebio Diagnostics, AB, Sweden, 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)

Alinity

Alinity i STAT High Sensitivity Troponin-I Controls

Single (Specified) Analyte Controls (Assayed And Unassayed)

Alinity

Alinity i Rubella IgG Controls

Single (Specified) Analyte Controls (Assayed And Unassayed)

Biocoach Glucose Control Solution L1/L2

Level 1 & 2

Single (Specified) Analyte Controls (Assayed And Unassayed)

Vitros

VITROS Immunodiagnostic Products Total ß-hCG II Range Verifiers

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM Calibrator A

Calibrator A - Atellica IM - CAL (6PK) 2 x 6 x 5.0 mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

PreciControl Rubella IgG

2 catalogue numbers from 09966625190, 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)

Triage

Quidel Triage® BNP Calibration Verification

Single (Specified) Analyte Controls (Assayed And Unassayed)

ProNephro AKI™ (Ngal) Control Kit

Catalogue number ST103UA, listed by Bioporto Diagnostics A/S, Denmark, 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® Lambda AMR Check Fluid SD

Catalogue number BP539.SD, 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)

Advia Centaur® Systems, ACS 180® Systems PSA MCM

Prostate-specific Antigen (PSA) Master Curve Material Kit

Single (Specified) Analyte Controls (Assayed And Unassayed)

PreciControl Vitamin D Total II

Catalogue number 07464266190, 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)

Pregnancy-Skreen

Kova poc, Pregnancy-Skreen hcG Liquid Control Urine, Negative and Positive Control, 5mL Kitbox

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM DHEAS2 MCM SET

Atellica IM DHEASII MCM SET

Single (Specified) Analyte Controls (Assayed And Unassayed)

Validate

VALIDATE Fertility 4 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Trinity Biotech

Hemoglobin A1c assay, Tri-stat Liquid Controls Kit

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur MH MCM Set

AMH - Centaur - Master Curve Material Kit 4 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems LH Calibration Verification Material LH

LH CVM - Immulite - Cons

Single (Specified) Analyte Controls (Assayed And Unassayed)

MAS Bilirubin Liquid Assayed Bilirubin Control

7 catalogue numbers from BC103, 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)

IDS Shbg Calibration Verifiers

Catalogue number IS-5635, 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)

Advia Centaur aHBe2 QC KIT

Anti-HBe2 (aHBe2) – ADVIA Centaur – QC Kit

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® 3RD GEN. PSA CVM

3rd Generation PSA CVM - IMMULITE – CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

CRP Quality Control Kit Level 3

CRP Quality Control Kit Level 3 for use with EasyRA Analyzer

Single (Specified) Analyte Controls (Assayed And Unassayed)

Smartest PersonaII

Smartest PersonaII Blood Glucose Monitoring System

Single (Specified) Analyte Controls (Assayed And Unassayed)

Gmate® Control Solution Level 1

Catalogue number PC-001, 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)

Accurun®

ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 4.0 mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM LH MCM

Luteinizing Hormone (LH) Atellica IM - Master Curve Material Kit 10 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Architect

ARCHITECT STAT High Sensitivity Troponin-I Controls

Single (Specified) Analyte Controls (Assayed And Unassayed)

Acrometrix BB NAT HBV Positive Control

Catalogue number 963603, 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)

Freelite® Kappa AMR Check Fluid SD

Catalogue number BP538.SD, 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)

Glucocard® Shine Level 2 Control Solution

GLUCOCARD Shine Level 2 Control Solution contains a specific amount of glucose that is used to check the performance of the meter and test strips. The test results you obtain should fall…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Glucocard® 01 Control

GLUCOCARD 01 Control contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Eurotrol AlbuTrol

Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Accu-Sed® Plus Norm & Abn ESR Control Set, 10×8.5ml

Catalogue number DS-71005A, 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)

Control Set SS2microglobulin

Catalogue number 08362785190, 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-HAV

Catalogue number 5524270160, 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)

Tosoh

Hemoglobin A1c Controls Levels 1 and 2, 4 vials of Level 1 Controls (0.25mL reconstituted), 4 Vials of Level 2 Controls (0.25mL reconstituted), 1 Package Insert

Single (Specified) Analyte Controls (Assayed And Unassayed)

Aptima®

The Mycoplasma genitalium in vitro transcript (IVT) controls are controls intended to be used with molecular assays that detect rRNA from Mycoplasma genitalium.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Yumizen C1200 L2 Cystatin C Control

Catalogue number 1300023953, 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)

Easy Plus II

Easy Plus II Blood Glucose Monitoring System 6276-S

Single (Specified) Analyte Controls (Assayed And Unassayed)

Brilliant Care

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)

Contour® Next Link

Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the following items: CONTOUR® NEXT LINK Blood Glucose Meter; 25 CONTOUR® NEXT Blood Glucose Test Strips; CONTOUR® NEXT…

Single (Specified) Analyte Controls (Assayed And Unassayed)

StatSensor

StatSensor Creat Linearity Level 1 - 5

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems TIE Calibration Verification Material Total IgE

IgE Total CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

ReliOn™ Premier Control Solution Level 2

ReliOn Premier Control Solution Level 2 contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Human C3c Control Pack for Use on the Spaplus®

Catalogue number NQ023.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® IgG1 Control Pack

Catalogue number NQ006.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)

ReliOn™ Premier Classic Meter

The ReliOn Premier Classic 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)

AIA-Pack 25-OH Vitamin D Control SET

AIA-Pack 25-OH Vitamin D 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)

Embrace EVO Control Solution, L1 (Low)

Catalogue number APX02AB0810, 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)

IDS-iSYS 25-Hydroxy Vitamin DS Control Set

Catalogue number IS-2730S, 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)

IDS Beta CrossLaps® (CTX-I) Calibrator Set

Catalogue number IS-3020N, 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)

G-6-PDH Normal Control (G-6-PDH Control N)

Catalogue number PD2618, 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)

Immulite® Systems FER Calibration Verification Material Ferritin

Ferritin CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Quanta Flash® aCL IgA Controls

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys CA 125 II CalCheck

Catalogue number 7762011190, 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 Dhea-S CalCheck 5

Catalogue number 5918014160, 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 Acth II Calibrator Set

Catalogue number IS-4520NG, 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)

uTASWako AFP-L3 Control H

2 catalogue numbers from 993-61101, 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)

Leader

LDR Glucose Control Solution 3x2mL solutions

Single (Specified) Analyte Controls (Assayed And Unassayed)

Access Inhibin a QC

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

StatStrip

StatStrip Xpress GLU Meter with Battery and Quick Reference Guide

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM T4 MCM

T4 Total (T4) Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Quanta Flash® Ro52 Controls

1. QUANTA Flash Ro52 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Ro52 in stabilizers and preservatives. 2.…

Single (Specified) Analyte Controls (Assayed And Unassayed)

G-6-PDH Deficient Control (G-6-PDH Control D)

Catalogue number PD2617, 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)

High CDT Control

Catalogue number 4772, 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)

PreciControl Cortisol Urine

Catalogue number 06687776190, 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)

Plasma Control

Plasma Control Level II, Malondialdeyhde in plasma/serum

Single (Specified) Analyte Controls (Assayed And Unassayed)

Lipase NG OC Ctrl 2

Lipase NG OC CTRL 2 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)

TRUEtrack

LEADER TRUEtrack Blood Glucose Meter – FREE METER ONLY – CANNOT SUBMIT FOR REIMBURSEMENT

Single (Specified) Analyte Controls (Assayed And Unassayed)

Dario Glucose Control Solution

Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitoring System manufactured by Labstyle Innovation Ltd. to check that the meter and test strips are working…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Architect

ARCHITECT Active-B12 (Holotranscobalamin) Controls

Single (Specified) Analyte Controls (Assayed And Unassayed)

CareTouch

CareTouch Glucose Control Solution

Single (Specified) Analyte Controls (Assayed And Unassayed)

TruCal Procalcitonin Calibrator Set

The TruCal Procalcitonin Calibrator Set is intended for in vitro use for calibration of the DiaSys Procalcitonin FS assay

Single (Specified) Analyte Controls (Assayed And Unassayed)

PreciControl Lp(A) Gen.2

2 catalogue numbers from 5852650160, 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 PTH QC

Intact parathyroid hormone (iPTH) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

uTASWako DCP Control L

2 catalogue numbers from 995-61301, 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)

Quanta Flash® ENA7 Controls

1. QUANTA Flash ENA7 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to ENA7 in buffer, stabilizers, and…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Optilite® C1 Inactivator Control Pack

Catalogue number NQ019.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 PTH MCM

Intact parathyroid hormone (iPTH) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Assure® Dose Normal (Level 1) Control Solution

Assure Dose Normal (Level 1) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems HCG Calibration Verification Material HCG

HCG CVM - Immulite - Cons

Single (Specified) Analyte Controls (Assayed And Unassayed)

DRI THC 125 Ng/ml Urine Control

2 catalogue numbers from 1404, 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)

IDS Cortisol Calibrator Set

Catalogue number IS-4620, 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)

Unassayed Testosterone QC Material

Unassayed Testosterone QC Material - 20 mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

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

Catalogue number DS-71003, 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)

PreciControl HSV

Catalogue number 5572207160, 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)

Plasma Control Bi-Level

Plasma Control Bi-Level, Malondialdeyhde in plasma/serum

Single (Specified) Analyte Controls (Assayed And Unassayed)

Breeze® 2

Control Solution - Normal, 1 x 2.5 mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM aCCP QC

anti-CCP IgG (aCCP) QC Kit Atellica IM - CLT 2 x 1 x 7.0 mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur EPO MCM

Erythropoietin (EPO) ADVIA Centaur - Master Curve Material Kit 5 x 1 x 1mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Gmate® Control Solution Level 2

Catalogue number PC-002, 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)

A1c-Cellular

A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains one vial each of Level 1 and 2.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Carolina Liquid Chemistries Corp.® Crea Reagent Product NO. DT243

CREA (Creatinine) 4 x 400 tests

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite Systems Total Testosterone CVM

Testosterone CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

IDS-iSYS 25 VitDS Calibration Verifiers

Catalogue number IS-2535, 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 Anti-CCP CalCheck

Catalogue number 5133181160, 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)

Fora

For use with GOD test strips

Single (Specified) Analyte Controls (Assayed And Unassayed)

GlucoLin

GlucoLin is an assayed quality control material for professional use to verify the performance characteristics of HemoCue® Glucose systems. Glucolin is intended for the quantitative…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® Active B12

Active B12 Control Set - CENTAUR - CTL - 1x2x7mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Alinity

Alinity i Active-B12 (Holotranscobalamin) Controls

Single (Specified) Analyte Controls (Assayed And Unassayed)

MedTest DX Elevated HCG Control Vial Label – B

Elevated HCG Control Vial Label - B, 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.…

Single (Specified) Analyte Controls (Assayed And Unassayed)

TeleMate Health &TeleRPM

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)

Optilite® Anti-Streptolysin O Control Pack

Catalogue number NQ189.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)

BioPlex 2200

BioPlex 2200 Syphilis Total & RPR Control Lot Data

Single (Specified) Analyte Controls (Assayed And Unassayed)

Medline

Cntrl, Mini, Normal, Single Patient USE

Single (Specified) Analyte Controls (Assayed And Unassayed)

PreciControl Maternal Care

Catalogue number 08740062160, 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 HE4 CalCheck 5

Catalogue number 5809452160, 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)

Pasma Control

MassCheck® Methylmalonic Acid Plasma Control Level II

Single (Specified) Analyte Controls (Assayed And Unassayed)

Cardinal Health

hCG Controls; 1 Set; IVD

Single (Specified) Analyte Controls (Assayed And Unassayed)

MAS Diabetes Liquid Assayed Diabetes Control

3 catalogue numbers from DBCL-MP, listed by Microgenics Corporation, United States, 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