Immunoassay, Insulin-Like Growth Factor Binding Protein-1

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are based in Jiangsu and Hunan: 4 hold an FDA registration.

AVE Science & Technology Co., Ltd. Hunan
Bioteke Corporation (Wuxi) Co., Ltd. Jiangsu
Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. Jiangsu
Wuxi Biohermes BIO & Medical Technology Co., Ltd. Jiangsu

What Is This Device?

The device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions. The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women.

How Is OAM Classified?

Immunoassay, Insulin-Like Growth Factor Binding Protein-1 is FDA product code OAM, Class 1, 21 CFR 862.1550.

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 Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2023. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Immunoassay, Insulin-Like Growth Factor Binding Protein-1

IGF-1 Elisa

Catalogue number KAP1581, listed by Diasource Immunoassays, S.A., United States, under Immunoassay, Insulin-Like Growth Factor Binding Protein-1. 4 manufacturers in China are registered for this product code.

Immunoassay, Insulin-Like Growth Factor Binding Protein-1

IDS-iSYS Insulin Like Growth Factor-1 (IGF-1)

Catalogue number IS-3900, listed by Immunodiagnostic Systems Ltd., United Kingdom, under Immunoassay, Insulin-Like Growth Factor Binding Protein-1. 4 manufacturers in China are registered for this product code.

Immunoassay, Insulin-Like Growth Factor Binding Protein-1

IDS-iSYS SDSpeed Calc

Catalogue number IS-SDSCALC, listed by Immunodiagnostic Systems Ltd., United Kingdom, under Immunoassay, Insulin-Like Growth Factor Binding Protein-1. 4 manufacturers in China are registered for this product code.

Immunoassay, Insulin-Like Growth Factor Binding Protein-1

Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (Immunochr

2 catalogue numbers from 20 tests/kit, listed by Jiangsu Macro & Micro-Test MED-Tech Co., Ltd., China, under Immunoassay, Insulin-Like Growth Factor Binding Protein-1. 4 manufacturers in China are registered for this product code.

Immunoassay, Insulin-Like Growth Factor Binding Protein-1

Actim Prom

Actim PROM test pouch. Each pouch includes: - One tube of Specimen Extraction Solution (0.5 mL). This phosphate-buffered solution contains bovine serum albumin (BSA), protease inhibitors…

Immunoassay, Insulin-Like Growth Factor Binding Protein-1

IGF-1-RIA-CT

Catalogue number KIP1588, listed by Diasource Immunoassays, S.A., United States, under Immunoassay, Insulin-Like Growth Factor Binding Protein-1. 4 manufacturers in China are registered for this product code.

Immunoassay, Insulin-Like Growth Factor Binding Protein-1

Actim Prom Controls

The Actim PROM Controls kit consists of one of each of the following components: 1. Actim PROM Negative Control (0 μg/L) 2. Actim PROM Low Positive Control (40 μg/L) 3. Actim PROM High…

Immunoassay, Insulin-Like Growth Factor Binding Protein-1

IGFBP-3 Elisa

Catalogue number KAP1171, listed by Diasource Immunoassays, S.A., United States, under Immunoassay, Insulin-Like Growth Factor Binding Protein-1. 4 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