Radioimmunoassay, C-Peptides of Proinsulin

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Jiangsu, Beijing and Guangdong, and 2 other provinces: 6 hold an FDA registration.

Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
Beijing Hotgen Biotech Co., Ltd. Beijing
Biobase Biodustry(Shandong)Co., Ltd. Shandong
Dirui Industrial Co., Ltd. Jilin, contract manufacturer
Getein Biotech, Inc. Jiangsu
Shenzhen Yhlo Biotech Co., Ltd. Guangdong

What Is FDA Product Code JKD?

Radioimmunoassay, C-Peptides Of Proinsulin is FDA product code JKD, Class 1, 21 CFR 862.1135.

How Does It Reach the US Market?

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 5 recalls under this product code since 2011. None was by a company in China. The root causes the FDA records most often are Device Design (2), Nonconforming Material/Component (1) and Employee error (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Radioimmunoassay, C-Peptides Of Proinsulin

Alpco C-Peptide Elisa

The ALPCO C-peptide ELISA is designed for the quantitative determination of C-peptide in human serum and plasma. For in vitro diagnostic use.

Radioimmunoassay, C-Peptides Of Proinsulin

C-Peptide AccuBind Elisa Test System – 96 Wells

Catalogue number 2725-300, listed by Monobind, Inc., United States, under Radioimmunoassay, C-Peptides Of Proinsulin. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, C-Peptides Of Proinsulin

Immulite® 2000 Systems PEP C-Peptide Sample Diluent

C-Peptide Sample Diluent - IMMULITE - CAL - 1x25mL

Radioimmunoassay, C-Peptides Of Proinsulin

Architect

ARCHITECT C-Peptide Reagent Kit

Radioimmunoassay, C-Peptides Of Proinsulin

Immulite®/Immulite® 1000 Systems PEP C-Peptide Sample Diluent

C-Peptide Sample Diluent - IMMULITE - 1x25mL

Radioimmunoassay, C-Peptides Of Proinsulin

C-Peptide & Insulin Diabetes Panel AccuBind Vast Elisa Test System – 96 Wells

Catalogue number 7325-300, listed by Monobind, Inc., United States, under Radioimmunoassay, C-Peptides Of Proinsulin. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, C-Peptides Of Proinsulin

C-PEP II-RIA-CT

Catalogue number KIP0409, listed by Diasource Immunoassays, S.A., United States, under Radioimmunoassay, C-Peptides Of Proinsulin. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, C-Peptides Of Proinsulin

Immulite®/Immulite® 1000 Systems PEP C-Peptide

C-Peptide - IMMULITE - RGT - 100 Tests

Radioimmunoassay, C-Peptides Of Proinsulin

AIA-Pack C-Peptide II Sample Diluting Solution

AIA-Pack C-Peptide II Sample Diluting Solution: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, C-Peptides Of Proinsulin. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, C-Peptides Of Proinsulin

Access C-Peptide

The Access C-Peptide assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of C-Peptide levels in human serum, plasma and urine using the Access…

Radioimmunoassay, C-Peptides Of Proinsulin

Stellux® Chemi Human C-Peptide Elisa

The ALPCO STELLUX™ C-peptide Chemiluminescence ELISA is designed for the quantitative determination of C-peptide in human serum, heparin plasma, EDTA plasma, and tissue culture…

Radioimmunoassay, C-Peptides Of Proinsulin

AccuDiag™ C-Peptide Elisa Kit

AccuDiag™ C-Peptide ELISA Kit A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-peptide in a clinical…

Radioimmunoassay, C-Peptides Of Proinsulin

C-Peptide AccuLite Clia Test System – 192 Wells

Catalogue number 2775-300, listed by Monobind, Inc., United States, under Radioimmunoassay, C-Peptides Of Proinsulin. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, C-Peptides Of Proinsulin

C-PEP-Easia

Catalogue number KPA0401, listed by Diasource Immunoassays, S.A., United States, under Radioimmunoassay, C-Peptides Of Proinsulin. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, C-Peptides Of Proinsulin

AIA-Pack C-Peptide Control Set

AIA-Pack C-Peptide Control Set: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, C-Peptides Of Proinsulin. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, C-Peptides Of Proinsulin

iFlash-C-Peptide

Catalogue number C86037, listed by Shenzhen Yhlo Biotech Co., Ltd., China, under Radioimmunoassay, C-Peptides Of Proinsulin. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, C-Peptides Of Proinsulin

Immulite® Systems CPE Control C-Peptide

C-Peptide - IMMULITE - CTL - 3x2mL

Radioimmunoassay, C-Peptides Of Proinsulin

Mercodia C-Peptide Elisa

Mercodia C-peptide ELISA provides a method for the quantitative determination of human C-peptide in serum, plasma or urine.

Radioimmunoassay, C-Peptides Of Proinsulin

Alinity

Alinity i C-Peptide Reagent Kit 200 Tests

Radioimmunoassay, C-Peptides Of Proinsulin

C-Peptide AccuLite Clia Test System – 96 Wells

Catalogue number 2775-300, listed by Monobind, Inc., United States, under Radioimmunoassay, C-Peptides Of Proinsulin. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, C-Peptides Of Proinsulin

Vitros

VITROS Immunodiagnostic Products C-peptide Reagent Pack

Radioimmunoassay, C-Peptides Of Proinsulin

Advia Centaur® CpS

C-Peptide - CENTAUR - RGT - 100 tests

Radioimmunoassay, C-Peptides Of Proinsulin

Proinsulin Elisa

The DRG Proinsulin ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Proinsulin (intact) in serum and plasma.

Radioimmunoassay, C-Peptides Of Proinsulin

Proinsulin Elisa

The DRG Proinsulin ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Proinsulin (intact) in serum and plasma.

Radioimmunoassay, C-Peptides Of Proinsulin

C-Peptide Elisa

The DRG C-Peptide ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of C-Peptide in serum, plasma (EDTA, lithium heparin or citrate plasma) and urine.

Radioimmunoassay, C-Peptides Of Proinsulin

Atellica IM CpS MCM

C-Peptide (CpS) Atellica IM - Master Curve Material Kit 10 x 1 x 1.0mL

Radioimmunoassay, C-Peptides Of Proinsulin

ST AIA-Pack C-Peptide II

ST AIA-Pack C-Peptide II: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, C-Peptides Of Proinsulin. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, C-Peptides Of Proinsulin

Stellux® Chemi Human C-Peptide Elisa Lab Pack

The ALPCO STELLUX® C-peptide Chemiluminescence ELISA is designed for the quantitative determination of C-peptide in human serum, heparin plasma, EDTA plasma, and tissue culture…

Radioimmunoassay, C-Peptides Of Proinsulin

Elecsys C-Peptide

2 catalogue numbers from 07027168190, listed by Roche Diagnostics Gmbh, Germany, under Radioimmunoassay, C-Peptides Of Proinsulin. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, C-Peptides Of Proinsulin

Monobind AccuBind C-Peptide & Insulin Vast Elisa Kit – 192 Wells

Catalogue number 7325-300, listed by Monobind, Inc., United States, under Radioimmunoassay, C-Peptides Of Proinsulin. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, C-Peptides Of Proinsulin

Immulite® 2000 Systems C-Peptide

C-Peptide - IMMULITE - RGT - 200 Tests

Radioimmunoassay, C-Peptides Of Proinsulin

Monobind AccuBind C-Peptide Elisa Kit – 192 Wells

Catalogue number 2725-300, listed by Monobind, Inc., United States, under Radioimmunoassay, C-Peptides Of Proinsulin. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, C-Peptides Of Proinsulin

Architect

ARCHITECT C-Peptide Reagent Kit

Radioimmunoassay, C-Peptides Of Proinsulin

C-Peptide & Insulin Diabetes Panel AccuLite Vast Clia Test System – 96 Wells

2 catalogue numbers from 7375-300, listed by Monobind, Inc., United States, under Radioimmunoassay, C-Peptides Of Proinsulin. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, C-Peptides Of Proinsulin

Mercodia Ultrasensitive C-Peptide Elisa

Mercodia Ultrasensitive C-peptide ELISA provides a method for the quantitative determination of human C-peptide in serum, plasma or urine.

Radioimmunoassay, C-Peptides Of Proinsulin

Stellux® Chemi Human Total Proinsulin Elisa

The Proinsulin (Total) Chemiluminescence ELISA is designed for the quantitative determination of proinsulin in human serum, plasma (EDTA and heparin), and tissue culture supernatants. For…

Radioimmunoassay, C-Peptides Of Proinsulin

Alpco C-Peptide Elisa Jumbo

The ALPCO C-peptide ELISA Jumbo is designed for the quantitative determination of C-peptide in human serum and plasma. For in vitro diagnostic use.

Radioimmunoassay, C-Peptides Of Proinsulin

Atellica IM CpS

C-Peptide (CpS) - Atellica IM - RGT 100T

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