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)

Elecsys PreciControl Troponin

Catalogue number 05095107160, 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)

B T M

Catalogue number 8228, listed by Biotest Medical Corp., Taiwan, 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)

Validate THY2

VALIDATE THY2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Optilite® Low Level IgG Control Pack

Catalogue number NQ004.LL.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)

EasyGluco™ Normal 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)

AIA-Pack AFP Calibration Verification Test Set

AIA-Pack AFP 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)

IDS-iSYS Ostase® BAP Control Set

Catalogue number IS-2830US, 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)

Optilite® Transferrin Control Pack

Catalogue number NQ070.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 Free T4 Linearity Kit

FREND™ Free T4 Linearity Kit is intended for use as an assayed linearity material for the free thyroxine (Free T4) on the FREND™ System. The Linearity Kit is for the FREND™ System only.…

Single (Specified) Analyte Controls (Assayed And Unassayed)

REP Cholesterol Profile Control (5 X 1 Ml)

Catalogue number 3218, 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)

Quanta Flash® LKM-1 Controls

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

Fruc Control 1

This product is intended for in vitro diagnostic use in the quality control of the Randox Liquid Fructosamine assay on clinical chemistry systems.

Single (Specified) Analyte Controls (Assayed And Unassayed)

HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls

Catalogue number 0009802116, 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)

On Call Express Voice Blood Glucose Monitoring System

Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)

Single (Specified) Analyte Controls (Assayed And Unassayed)

Access Intrinsic Factor Ab QC

The Access Intrinsic Factor Ab QC is intended for monitoring system performance of the Access Intrinsic Factor Ab assay.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Embrace Talk Control Solution HI

Embrace TALK control solution L2

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM aHBe2 QC

Anti-HBe2 (aHBe2) – Atellica IM – QC Kit

Single (Specified) Analyte Controls (Assayed And Unassayed)

Dimension Vista® / Dimension® EXL™ Lctni CON M

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

Eurotrol GlucoTrol-AQ

Eurotrol GlucoTrol-AQ is an assayed glucose control intended for professional use in the verification of the precision and accuracy of the HemoCue Glucose 201 analyzer. A box of Eurotrol…

Single (Specified) Analyte Controls (Assayed And Unassayed)

BD Veritor™ System Flu A+B Control Swab Set

10 ea. Flu A+/B- Control Swabs, 10 ea. Flu A-/B+ Control Swabs

Single (Specified) Analyte Controls (Assayed And Unassayed)

HCG Serum Control KIT

Catalogue number 138, 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)

IDS-iSYS 1,25-Dihydroxy Vitamin D Calibration Verifiers

Catalogue number IS-2435, 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)

AIA-Pack Intact PTH Control SET

AIA-Pack Intact PTH 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)

Optilite® IgG2 Control Pack

Catalogue number NQ007.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)

IDS Androstenedione Control Set

Catalogue number IS-5430, 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)

AimStrip Tandem Glucose Control Solution

blood glucose meter and test strip control solution-level 1,2,3

Single (Specified) Analyte Controls (Assayed And Unassayed)

Dropper A1c Diabetes Control Level 1&2 Set 4×0.9ml

The Dropper A1c Diabetes Control is intended for the quality control of analytical procedures used to quantitate HbA1c. It is supplied in two levels as a frozen, ready-to-use material that…

Single (Specified) Analyte Controls (Assayed And Unassayed)

IDS-iSYS 1,25-Dihydroxy Vitamin D Control Set

Catalogue number IS-2430, 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)

LipidPlus® Meter

Catalogue number MD550, listed by Jant Pharmacal 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)

Elecsys Troponin I CalCheck 5

Catalogue number 5931550160, 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)

Pip Control Solution High

Catalogue number PC003-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)

EasyGluco™G2 Starter 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)

WowGoHealth Control Solution – GSH-BGM902 – Level 1

The WowGoHealth Control Solution should be tested on WowGoHealth meter using WowGoHealth test strips to make sure the meter and test strips are working properly.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems BP-3 Calibration Verification Material IGBP-3

IGFBP-3 CVM - Immulite - Cons

Single (Specified) Analyte Controls (Assayed And Unassayed)

Quanta Flash® CCP3 Controls

1. QUANTA Flash CCP3 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to CCP3 in stabilizers and preservatives. 2.…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Stat Profile

Prime ABG w/ Scanner Analyzer

Single (Specified) Analyte Controls (Assayed And Unassayed)

Easy Step Control Solution – High

Catalogue number T506-66, listed by Home Aide 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)

EmbraceWAVE Glucose Control Solution Low (L1)

Control Solution Low (Level 1)

Single (Specified) Analyte Controls (Assayed And Unassayed)

Nova Lite® IFA Hu (ANNA-1) Positive Control

1 x 0.5 Hu (ANNA-1) Positive Control

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys PTH CalCheck 5

Catalogue number 5918103160, 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 HBV Mid Control

Catalogue number 965002, 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)

Method Verification Kit – Vitamin D

Catalogue number Vit. D Verifier, listed by Qualigen, 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)

CalSet PTH Stat

Catalogue number 08928509190, 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 IgD Control Pack for Use on the Siemens Bn™ii

Catalogue number NQ013.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)

Elecsys C-Peptide CalCheck 5

Catalogue number 5918065160, 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)

Control for Lucica® Glycated Albumin-L

Control L (3 mL × 1), Control H (3 mL × 1)

Single (Specified) Analyte Controls (Assayed And Unassayed)

PreciControl CMV IgM

Catalogue number 4784626190, 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 CEA CalCheck 5

Catalogue number 5917883160, 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)

Urine Control Bi-Level

MassCheck® Methylmalonic Acid Urine Control Bi-Level

Single (Specified) Analyte Controls (Assayed And Unassayed)

Ammonia Alcohol Control Level 3 Set 3x5ml

Catalogue number 1313-31, 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)

ReliOn™ Confirm/Micro Control

ReliOn Confirm/Micro 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. Compare the control…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Optilite® C3c Control Pack

Catalogue number NQ023.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)

sLDL Control – Level 1 (sLDL Control 1)

Catalogue number LE5013, 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)

HemosIL AcuStar Anti-B2GPI Domain 1 Controls

1. HemosIL Acustar 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. HemosIL…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Igra Control Set

The IGRA Control Set contains human recombinant Interferon-gamma (IFN-g), and is intended for use as an optional, unassayed quality control material for assays detecting IFN-g. The IGRA…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Acrometrix HIV P24

Catalogue number 960038, 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)

Atellica IM PCT MCM

Procalcitonin (PCT) Atellica IM - Master Curve Material 5 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Optilite® Hevylite® IgA Kappa Control Pack

Catalogue number NQ623.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)

MAS PTH Control Liquid Assayed PTH Control

Catalogue number PTH-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.

Single (Specified) Analyte Controls (Assayed And Unassayed)

CalCheck Vitamin D Total III

Vitamin D total G3 CC 5 Elecsys

Single (Specified) Analyte Controls (Assayed And Unassayed)

Fruc Control 3

This product is intended for in vitro diagnostic use in the quality control of the Randox Liquid Fructosamine assay on clinical chemistry systems.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Liaison® 25 OH Vitamin D Total Calibration Verifiers

Catalogue number 310603, 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)

Elecsys Estradiol III CalCheck

Catalogue number 7443471190, 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-iSYS Insulin Like Growth Factor-I (IGF-1) Calibration Verifiers

The IDS-iSYS IGF-I Calibration Verifier checks calibration of the IDS-iSYS IGF-I assay on the IDS-iSYS Multi-Discipline Automated Analyzer. It is a calibration verification material for use…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM CEA MCM

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

Alfa Wassermann

Catalogue number C2-86, listed by Alfa Wassermann, 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)

HbA1c Quality Control Kit Level 2

HbA1c Quality Control Kit Level 2 for use with EasyRA Analyzer

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® FT3 MCM

Free T3 Master Curve Material - CENTAUR - CONS

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