Radioimmunoassay, Immunoreactive Insulin

Which Manufacturers in China Make This?

4 manufacturers in China hold an FDA registration for this device type, concentrated in Beijing, Guangdong and Jiangsu, and 1 other province.

Beijing Hotgen Biotech Co., Ltd. Beijing
Dirui Industrial Co., Ltd. Jilin, contract manufacturer
Getein Biotech, Inc. Jiangsu
Shenzhen Yhlo Biotech Co., Ltd. Guangdong

How Is CFP Classified?

Radioimmunoassay, Immunoreactive Insulin is FDA product code CFP, Class 1, 21 CFR 862.1405.

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 8 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Component change control (2), Nonconforming Material/Component (2) and Device Design (1).

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

Radioimmunoassay, Immunoreactive Insulin

Stellux® Chemi Human Insulin Elisa

The ALPCO Insulin Chemiluminescence ELISA is designed for the quantitative determination of insulin in human serum, heparin plasma, and tissue culture supernatants. For in vitro diagnostic…

Radioimmunoassay, Immunoreactive Insulin

Alpco Insulin Elisa Jumbo

The ALPCO Insulin ELISA is designed for the quantitative determination of insulin in serum and plasma. For in vitro diagnostic use.

Radioimmunoassay, Immunoreactive Insulin

Alpco Ultrasensitive Insulin Elisa Jumbo

The ALPCO Ultrasensitive Insulin ELISA Jumbo is designed for the quantitative determination of insulin in human serum and plasma. For in vitro diagnostic use.

Radioimmunoassay, Immunoreactive Insulin

AIA-100

Catalogue number KIP0091, listed by Diasource Immunoassays, S.A., United States, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Immunoreactive Insulin

INS Elisa

Catalogue number KAP1251, listed by Diasource Immunoassays, S.A., United States, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Immunoreactive Insulin

AIA-Pack IRI Calibrator SET

AIA-Pack IRI Calibrator SET: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Immunoreactive Insulin

Vitros

VITROS Immunodiagnostic Products Insulin Reagent Pack

Radioimmunoassay, Immunoreactive Insulin

AccuDiag™ Insulin Elisa

AccuDiag™ Insulin ELISA A collection of reagents and other associated materials intended to be used for the quantitative measurement of insulin in a clinical specimen, using an enzyme…

Radioimmunoassay, Immunoreactive Insulin

Mercodia Iso-Insulin Elisa

Mercodia Iso-Insulin ELISA provides a method for the quantitative determination of insulin in human serum or plasma.

Radioimmunoassay, Immunoreactive Insulin

Mercodia Insulin Elisa

Mercodia Insulin ELISA provides a method for the quantitative determination of human insulin in serum or plasma.

Radioimmunoassay, Immunoreactive Insulin

Atellica IM IRI

Insulin (IRI) - Atellica IM - RGT 100T

Radioimmunoassay, Immunoreactive Insulin

Immulite® INS Control Insulin

Insulin Module - IMMULITE - CTL - 2x5mL

Radioimmunoassay, Immunoreactive Insulin

Insulin Rapid AccuBind Elisa Test System – 192 Wells

Catalogue number 5825-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Immunoreactive Insulin

Alpco Insulin Elisa

The ALPCO Insulin ELISA is designed for the quantitative determination of insulin in serum and plasma. For in vitro diagnostic use.

Radioimmunoassay, Immunoreactive Insulin

Immulite®/Immulite® Systems 1000 Systems INS Insulin Sample Diluent

Insulin Sample Diluent - IMMULITE - CAL - 1x25mL

Radioimmunoassay, Immunoreactive Insulin

Alinity

Alinity i Insulin Reagent Kit 200 Tests

Radioimmunoassay, Immunoreactive Insulin

Monobind AccuBind Insulin Rapid Elisa Kit – 96 Wells

Catalogue number 5825-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Immunoreactive Insulin

Insulin Elisa

The DRG Insulin ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Insulin in serum and plasma (lithium heparin or EDTA plasma).

Radioimmunoassay, Immunoreactive Insulin

AIA-Pack IRI Sample Diluting Solution

AIA-Pack IRI Sample Diluting Solution: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Immunoreactive Insulin

iFlash-Insulin

Catalogue number C86036, listed by Shenzhen Yhlo Biotech Co., Ltd., China, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Immunoreactive Insulin

Anti-Insulin Elisa

Anti-Insulin ELISA is a test system for the quantitative measurement of IgG class autoantibodies against insulin in human serum or plasma.

Radioimmunoassay, Immunoreactive Insulin

Anti-Insulin Elisa

Anti-Insulin ELISA is a test system for the quantitative measurement of IgG class autoantibodies against insulin in human serum or plasma.

Radioimmunoassay, Immunoreactive Insulin

Stellux® Chemi Human Insulin Elisa Jumbo

The ALPCO Insulin Chemiluminescence ELISA Jumbo is designed for the quantitative determination of insulin in human serum, heparin plasma, and tissue culture supernatants. For in vitro…

Radioimmunoassay, Immunoreactive Insulin

Architect

ARCHITECT Insulin Reagent Kit

Radioimmunoassay, Immunoreactive Insulin

Advia Centaur® IRI DIL

Insulin Dil.RP (2PK) - CENTAUR - CAL - 2x10mL

Radioimmunoassay, Immunoreactive Insulin

AIA-Pack IRI Control SET

AIA-Pack IRI Control SET: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Immunoreactive Insulin

K-Assay® Insulin Reagent (L)

For the quantitative determination of human insulin in serum and plasma by immunoturbidimetric assay.

Radioimmunoassay, Immunoreactive Insulin

Advia Centaur® IRI

Insulin Diluent - CENTAUR - CAL - 1x10mL

Radioimmunoassay, Immunoreactive Insulin

ST AIA-Pack IRI

ST AIA-Pack IRI: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Immunoreactive Insulin

Insulin AccuLite Clia Test System – 96 Wells

Catalogue number 2475-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Immunoreactive Insulin

Insulin

The DRG:HYBRId-XL Insulin is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Insulin in serum and plasma (EDTA and Heparin).

Radioimmunoassay, Immunoreactive Insulin

Alpco Ultrasensitive Insulin Elisa

The ALPCO Ultrasensitive Insulin ELISA is designed for the quantitative determination of insulin in human serum and plasma. For in vitro diagnostic use.

Radioimmunoassay, Immunoreactive Insulin

Atellica IM IRI DIL

Insulin (IRI) Diluent Bottle Atellica IM - CONS) 1 x 10mL

Radioimmunoassay, Immunoreactive Insulin

INS-Irma

Catalogue number KIP1251/KIP1254, listed by Diasource Immunoassays, S.A., United States, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Immunoreactive Insulin

Mercodia Insulin Elisa 10 Pack

Mercodia Insulin ELISA provides a method for the quantitative determination of human insulin in serum or plasma.

Radioimmunoassay, Immunoreactive Insulin

Immulite®/Immulite® 1000 Systems INS Insulin

Insulin - IMMULITE - RGT - 100 Tests

Radioimmunoassay, Immunoreactive Insulin

Insulin AccuBind Elisa Test System – 192 Wells

Catalogue number 2425-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Immunoreactive Insulin

Immulite® 2000 Systems INS Insulin

Insulin - IMMULITE - RGT - 600 Tests

Radioimmunoassay, Immunoreactive Insulin

K-Assay® Insulin Reagent

For the quantitative determination of human insulin in serum and plasma by immunoturbidimetric assay.

Radioimmunoassay, Immunoreactive Insulin

Insulin Elisa

The DRG Insulin ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Insulin in serum and plasma (lithium heparin or EDTA plasma).

Radioimmunoassay, Immunoreactive Insulin

Insulin

The DRG:HYBRId-XL Insulin is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Insulin in serum and plasma (EDTA and Heparin).

Radioimmunoassay, Immunoreactive Insulin

Insulin AccuLite Clia Test System – 192 Wells

Catalogue number 2475-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Immunoreactive Insulin

Elecsys Insulin

2 catalogue numbers from 12017547122, listed by Roche Diagnostics Gmbh, Germany, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Immunoreactive Insulin

K-Assay® Insulin Calibrator

For the calibration of the K-ASSAY® Insulin assay.

Radioimmunoassay, Immunoreactive Insulin

Salimetrics

Salivary Insulin Elisa Kit (5-pack)

Radioimmunoassay, Immunoreactive Insulin

Mercodia Ultrasensitive Insulin Elisa

Mercodia Ultrasensitive Insulin ELISA provides a method for the quantitative determination of insulin in human serum or plasma.

Radioimmunoassay, Immunoreactive Insulin

Insulin AccuBind Elisa Test System – 96 Wells

Catalogue number 2425-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Immunoreactive Insulin

Insulin Elisa Kit (Dako)

Insulin ELISA Kit provides a method for the quantitative determination of human insulin in serum or plasma. As with all diagnostic tests, a definitve clinical diagnosis should not be based…

Radioimmunoassay, Immunoreactive Insulin

Architect

ARCHITECT Insulin Reagent Kit

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