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)

Poly Stat

Qualitative HCG Control, Urine

Single (Specified) Analyte Controls (Assayed And Unassayed)

Accurun® Anti-SARS-CoV-2 Controls Kit Series 1000

Catalogue number 2015-0222, listed by LGC Clinical 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)

Atellica IM HCY MCM

Homocysteine (HYC) Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Optilite® Low Level Total Protein Controls

Catalogue number NQ061.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)

sLDL Control – Level 3 (sLDL Control 3)

Catalogue number LE5015, 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)

Acrometrix EV Negative Control

Catalogue number 960499, 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)

Urine Control

MassCheck® Methylmalonic Acid Urine Control Level II

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Growth Hormone CVM

Growth Hormone CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM H2n MCM

Her-2/neu (H2n) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems TG Calibration Verification Material Thyroglobulin

Thyroglobulin CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Assure® Prism Control Solution

Assure Prism Control Solution 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…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Architect

ARCHITECT Total PSA Reagent Kit

Single (Specified) Analyte Controls (Assayed And Unassayed)

Accu-Chek Inform II

Accu-Chek Inform II controls US 10/CS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Optilite® Hevylite® IgM Lambda Control Pack

Catalogue number NQ626.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® Centromere Controls

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

CalSet II PTH

Catalogue number 08928487190, 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)

K-Check Controls

The K-CHECK Controls are intended to be used by trained laboratory professionals to evaluate and verify the expected accuracy and performance of K-CHECK Reagent tablets. The set of three…

Single (Specified) Analyte Controls (Assayed And Unassayed)

InteliQ

InteliQ Homocysteine Control Level 2 (A human serum assayed homocysteine control.)

Single (Specified) Analyte Controls (Assayed And Unassayed)

Quanta Flash® DGP IgG Controls

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

Embrace Control Solution, L2 (High)

Catalogue number APX02AB0311, 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)

Human IgG Subclass Control Pack for Use on the Spaplus®

Catalogue number NQ006.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)

HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls

Catalogue number 0009802112, 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)

“Total Antioxidant Status (TAS Control)”

This product is intended for use in the control of the Randox Total Antioxidant Status assay,

Single (Specified) Analyte Controls (Assayed And Unassayed)

IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set

2 catalogue numbers from IS-4430, 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)

Rightest

Rightest Control Solution GC300 is an aqueous glucose control solution. The filing describes it as containing a measured amount of glucose that reacts with test strips to provide a…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Accurun® 2 Series 5600

Catalogue number 2000-0100, listed by LGC Clinical 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)

Immulite® Systems ACT Control Acth

ACTH - IMMULITE - CTL - 2x2mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM Shbg MCM

Sex Hormone Binding Globulin (SHBG) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM Herpes-1 IgG Quality Control

Herpes-1 IgG (HSV1) Atellica IM - Quality Control

Single (Specified) Analyte Controls (Assayed And Unassayed)

Optilite® Beta-2 Microglobulin Control Pack

Catalogue number NQ043.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® Systems FT3 Calibration Verification Material Free T3

FreeT3 CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® COR MCM

Cortisol - Master Curve Material Set - CENTAUR - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM TnI-Ultra MCM

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems INS Calibration Verification Material Insulin

Insulin CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

CalCheck IGFBP-3

Catalogue number 07574797190, 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 EBV High Plasma Control

Catalogue number 961231, 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)

On Call Vivid Blood Glucose Monitoring System

The On Call Vivid Blood Glucose Monitoring System measures glucose in fresh capillary whole blood for people with diabetes monitoring their condition at home. The meter reads an electrical…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM VitD MCM

Vitamin D total 25 (OH) (VitD) Atellica IM Master Curve Material Kit 5 x 2 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Autokit Micro Albumin Calibrator Set

2 catalogue numbers from 995-06101, 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)

Embrace EVO Control Solution, L2 (Medium)

Catalogue number APX02AB0811, 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)

Advia Centaur® T4 MCM

Advia Centaur T4 Master Curve Material checks calibration and the reportable range of the Advia Centaur thyroxine assay. It is an in vitro diagnostic quality-control material for use on…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Serum Control Bi-Level

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

IDS-iSYS 17-OH Progesterone Calibration Verifiers

IDS-iSYS 17-OH Progesterone Calibration Verifiers check the calibration and measuring range of the corresponding assay on the IDS-iSYS Multi-Discipline Automated System. They are…

Single (Specified) Analyte Controls (Assayed And Unassayed)

K-Assay® Beta-2 Microglobulin / Ferritin – Serum / Plasma Control

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

THC Control 1

The Randox Cannabinoid Control - Level 1 is intended for use in the Quality Control of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay. The Cannabinoid Control Level 1 contains the specific…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Hologic

NG IVT Wild Type Control (Negative Control).

Single (Specified) Analyte Controls (Assayed And Unassayed)

AMH CalCheck 5

Catalogue number 06331092190, 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 MYO MCM

Myoglobin (MYO) Atellica IM - Master Curve Material Kit 8 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

True Focus

Walgreens TRUE FOCUS Self Monitoring Blood Glucose Meter box

Single (Specified) Analyte Controls (Assayed And Unassayed)

Active Vitamin B12 Control Level 1

The Active Vitamin B12 Control Level 1 is intended for use with in vitro diagnostic assays for the quantitative determination of active Vitamin B12 (Holotranscobalamin/HoloTC) in human…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys HCG Stat CalCheck 5

Catalogue number 5579082160, 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)

TruLab Procalcitonin Bi-Level Controls

TruLab Procalcitonin Bi-Level Controls are an assayed quality control material for monitoring the performance of quantitative in vitro determination of procalcitonin (PCT) for the DiaSys…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM AMH QC Kit

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys Prolactin II CalCheck 5

Catalogue number 6267564160, 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)

Isatuximab Control

Catalogue number 4764, 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)

Accurun® Anti-SARS-CoV-2 Controls Kit Series 2000

Catalogue number 2015-0225, listed by LGC Clinical 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)

Advia Centaur ELF MCM SET

Catalogue number 11208709, 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)

Quanta Flash RF IgM Controls

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® iPTH MCM

PTH Intact Master Curve Material Set - CENTAUR - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

DRI THC 75 Ng/ml Urine Control

Catalogue number 0214, 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)

AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome

AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome (Positive and Negative member-5 X 1.5 ml)

Single (Specified) Analyte Controls (Assayed And Unassayed)

MedTest DX Elevated HCG Control Vial Label – A

Elevated HCG Control Vial Label - 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.…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® CpS MCM

C-Peptide S Master Curve Material Kit - CENTAUR - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Pointe Lipoprotein (A) Control Set

Pointe Lipoprotein (a) Control Set, 1 x 1ml L1, 1 x 1ml L2, For use in monitoring the quality control of results obtained with the Pointe Lipoprotein(a) Assay reagents by turbidimetry. For…

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM VB12 MCM

Vitamin B12 (VB12) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Optilite® IgA2 Control Pack

Catalogue number NQ088.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)

Advia Centaur® IRI MCM

Insulin Master Curve Material - CENTAUR - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Acrometrix BKV High Control

Catalogue number 960051, 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® Panel Sample Set

Catalogue number BP228, 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 Herpes-1 IgG Quality Control

Herpes-1 IgG (HSV1) ADVIA Centaur - Quality Control

Single (Specified) Analyte Controls (Assayed And Unassayed)

Dropper Spinal Fluid Control Level 1 Set 3x3ml

Catalogue number 1451-31, 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)

A1AT Controls

Catalogue number 3435, 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)

Eocene

Smart Diabetes Bluetooth Glucose Monitor

Single (Specified) Analyte Controls (Assayed And Unassayed)

ONE-Care

ONE-CARE Control Solution (Level 1 – Low and Level 3 - High) contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed…

Single (Specified) Analyte Controls (Assayed And Unassayed)

MediSense

MediSense Glucose & Ketone Control Solutions

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur Tumor Marker Quality Control (TM QC)

Tumor Marker - ADVIA Centaur - Quality Control

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica™ IM Fol MCM

Folic Acid (Fol) - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Freelite Kappa Free Panel Sample Set

Catalogue number BP233, 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)

Diabetes Cntl, Smpl, 1x2x0.5ml

Diabetes Control Sample Pack

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM CsA MCM

Cyclosporine (CsA) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Glutathione Reductase Control Serum (Glut RED Control)

Catalogue number GR2608, 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)

MAS Diabetes Max-SP (Sample-Pack)

Catalogue number B40000688, 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)

Advia Centaur® Valp MCM

Valproic Acid Master Curve Material Set - CENTAUR - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

CRP Quality Control Kit Level 1

CRP Quality Control Kit Level 1 for use with EasyRA Analyzer

Single (Specified) Analyte Controls (Assayed And Unassayed)

Carolina Liquid Chemistries Corp.® HCY Level 3 Control KIT Part# CC053

HCY (Homocysteine) Level 3 control 6 x 5 mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Acrometrix EBV Low Plasma Control

Catalogue number 961230, 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)

Daratumumab Control

Catalogue number 4765, 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)

uTASWako AFP-L3 Control L

2 catalogue numbers from 997-61001, 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)

Immulite Systems Unconjugated Estriol (Ue3) CVM

Catalogue number 10707265, listed by Siemens Healthcare Diagnostics Products 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)

Afinion HbA1c Calibration Verification

HbA1c Calibration Verification for use with the Afinion HbA1c Dx test. Content: Control samples L1, L2 and L3, 1 package insert.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys Digoxin CalCheck 5

Catalogue number 5917999160, 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)

MIO

Mio Control Solution

Single (Specified) Analyte Controls (Assayed And Unassayed)

Glucocard® Shine Level 1 Control Solution

GLUCOCARD Shine Level 1 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)

Optilite® IgG Control Pack

Catalogue number NQ004.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)

Advia Centaur® ACS: 180® Calibrator A

Thyroid (2PK) - CENTAUR - CAL - 2x2x5mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

N Lp(A) Control SY

Assayed control for Lp(a) assay on BN Systems

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advocate Control Solutions Low

Advocate Control Solutions Level 1 Low 4 ml Bottle

Single (Specified) Analyte Controls (Assayed And Unassayed)

CalChecks Total-Tau

Catalogue number 07546459190, listed by Roche Diagnostics Gmbh, Germany, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite 2000 Systems Folic Acid Calibration Verification Material

Folate Acid CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems AFP Calibration Verification Material

AFP CVM - Immulite - Cons

Single (Specified) Analyte Controls (Assayed And Unassayed)

BD Veritor SARS-CoV-2 Control Swab Set

Veritor COVID Gen 2 control swab set

Single (Specified) Analyte Controls (Assayed And Unassayed)

Immulite® Systems fPS Calibration Verification Material Free PSA

Free PSA CVM - IMMULITE - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

sLDL Control – Level 2 (sLDL Control 2)

Catalogue number LE5014, 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)

OneTouch Verio Control Solution

Catalogue number 011818, listed by Lifescan Europe Gmbh, Switzerland, under Single (Specified) Analyte Controls (Assayed And Unassayed). 12 manufacturers in China are registered for this product code.

Single (Specified) Analyte Controls (Assayed And Unassayed)

Trinity Biotech

ACE Control-E

Single (Specified) Analyte Controls (Assayed And Unassayed)

Atellica IM AB12 QC

Active-B12 (AB12) QC Kit Atellica IM - CLT 2 x 1 x 7.0mL

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur NT-Pbnpii (Pbnpii)

PBNPII - ADVIA Centaur - MCM Set

Single (Specified) Analyte Controls (Assayed And Unassayed)

ACE Control Set

ACE Control Set is intended to be used with Sentinel ACE Liquid Reagent to monitor the accuracy and precision of the kinetic determination of angiotensin converting enzyme (ACE) assay in…

Single (Specified) Analyte Controls (Assayed And Unassayed)

FreeStyle

FreeStyle Control Solution

Single (Specified) Analyte Controls (Assayed And Unassayed)

Myoglobin Control Set

Catalogue number 11730835216, 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)

Ultimate

Ultimate -D Bilirubin Control Level 2

Single (Specified) Analyte Controls (Assayed And Unassayed)

Cystatin C Control – Level 3 (Cysc Control 3)

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

AMH Control Level 3 (AMH Control 3)

The AMH Control Level 3 (AMH10515) 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)

Curaplex

Curaplex Control Solution 2/BT

Single (Specified) Analyte Controls (Assayed And Unassayed)

Advia Centaur® Testosterone 2 MCM

Testosterone 2 Master Curve Material SET - CENTAUR - CONS

Single (Specified) Analyte Controls (Assayed And Unassayed)

PreciControl Rubella IgM

2 catalogue numbers from 09787518190, 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)

Quanta Flash® h-tTG IgG Controls

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

Single (Specified) Analyte Controls (Assayed And Unassayed)

Nefa Linearity Material

Catalogue number 997-76491, 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)

AgaMatrix

Control Solution, AgaMatrix, Combo Normal and High

Single (Specified) Analyte Controls (Assayed And Unassayed)

Elecsys Acth CalCheck

Catalogue number 3562140190, 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