Radioimmunoassay, Follicle-Stimulating Hormone

Who Makes This Device Type in China?

6 manufacturers in China hold an FDA registration for this device type, concentrated in Beijing, Guangdong and Hebei, and 3 other provinces.

AVE Science & Technology Co., Ltd. Hunan
Beijing Hotgen Biotech Co., Ltd. Beijing
Dirui Industrial Co., Ltd. Jilin, contract manufacturer
Getein Biotech, Inc. Jiangsu
Shenzhen Yhlo Biotech Co., Ltd. Guangdong
Shijiazhuang Hipro Biotechnology Co., Ltd. Hebei

How Is CGJ Classified?

Radioimmunoassay, Follicle-Stimulating Hormone is FDA product code CGJ, Class 1, 21 CFR 862.1300.

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 9 recalls under this product code since 2012. None was by a company in China. The root causes the FDA records most often are Device Design (3) and Nonconforming Material/Component (3).

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

Radioimmunoassay, Follicle-Stimulating Hormone

AccuDiag™ FSH Elisa

Catalogue number DACD4224-15, listed by Diagnostic Automation, Inc., under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

FSH AccuLite Clia Test System – 192 Wells

Catalogue number 475-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

Access hFSH Calibrators

The Access hFSH Calibrators are intended to calibrate the Access hFSH assay for the quantitative determination of follicle stimulating hormone (FSH) levels in human serum and plasma using…

Radioimmunoassay, Follicle-Stimulating Hormone

One Step Menopausal Test

Catalogue number 21001, listed by Universal Corporation Limited, India, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

Immulite®/Immulite® 1000 Systems FSH

FSH - IMMULITE - RGT - 100 Tests

Radioimmunoassay, Follicle-Stimulating Hormone

Pointe Scientific, Inc.

FSH for the quantitative determination of FSH concentration in human serum. The assay is useful in the diagnosis and treatment of pituitary and gonadal disorders. 96 Tests.

Radioimmunoassay, Follicle-Stimulating Hormone

Vidas® FSH

VIDAS® FSH (FSH) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the detection of FSH concentration in human serum or plasma

Radioimmunoassay, Follicle-Stimulating Hormone

FSH AccuBind Elisa Test System – 192 Wells

Catalogue number 425-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

Advia Centaur® FSH MCM

Follicular Stimulating Hormone Master Curve Material Set - CENTAUR - CONS

Radioimmunoassay, Follicle-Stimulating Hormone

iFlash-FSH

Catalogue number C86011, listed by Shenzhen Yhlo Biotech Co., Ltd., China, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

Delfia hFSH Kit

Time-resolved fluoroimmunoassay for the quantitative determination of human follicle stimulating hormone (hFSH).

Radioimmunoassay, Follicle-Stimulating Hormone

DBC Follicle Stimulating Hormone (FSH) Elisa

For the quantitative measurement of Follicle Stimulating Hormone (FSH) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use.

Radioimmunoassay, Follicle-Stimulating Hormone

Immulite®/Immulite® 1000 Systems FSH Sample Diluent

FSH Sample Diluent - IMMULITE - 1x25mL

Radioimmunoassay, Follicle-Stimulating Hormone

ST AIA-Pack FSH

ST AIA-Pack FSH: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

FSH

Catalogue number HYE-5355, listed by DRG Instruments Gesellschaft mit beschränkter Haftung, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

Atellica IM FSH MCM

Follicle Stimulating Hormone (FSH) Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL

Radioimmunoassay, Follicle-Stimulating Hormone

Instant-View FSH Midstream Cassette Test, 2t

Catalogue number 02-2560-2, listed by Alfa Scientific Designs, Inc., United States, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

Instant-View FSH Dip-Strip Test

Catalogue number 02-2567, listed by Alfa Scientific Designs, Inc., United States, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

FSH Elisa

For the Quantitative Determination of Follicle Stimulating Hormone Concentration in Human Serum by a Microplate Enzyme Immunoassay, Colorimetric.

Radioimmunoassay, Follicle-Stimulating Hormone

FSH

Catalogue number HYE-5355, listed by DRG International, Inc., United States, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

Instant-View FSH Cassette Test

Catalogue number 02-2562, listed by Alfa Scientific Designs, Inc., United States, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

Immulite® 2000 Systems FSH FSH Sample Diluent

FSH Sample Diluent - IMMULITE - 1x25mL

Radioimmunoassay, Follicle-Stimulating Hormone

FSH AccuBind Elisa Test System – 96 Wells

Catalogue number 425-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

Immulite 2000 FSH Kit Domestic 600t

Catalogue number 10901859, listed by Siemens Healthcare Diagnostics Products GmbH, Germany, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

Monobind AccuLite FSH, hCG, LH & PRLs Vast Clia Kit – 960 Wells

3 catalogue numbers from 8375-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

Vitros

VITROS Immunodiagnostic Products FSH Reagent Pack

Radioimmunoassay, Follicle-Stimulating Hormone

Alinity

Alinity i FSH Reagent Kit 1200 Tests

Radioimmunoassay, Follicle-Stimulating Hormone

CL AIA-Pack FSH Test CUP

CL AIA-Pack FSH Test CUP: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

Instant-View FSH Midstream Cassette Test

Catalogue number 02-2560, listed by Alfa Scientific Designs, Inc., United States, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

Follicle Stimulating Hormone (FSH) Elisa

Intended for the direct quantitative determination of Follicle Stimulating Hormone (FSH) by an enzyme immunoassay in human serum. For in vitro diagnostic use.

Radioimmunoassay, Follicle-Stimulating Hormone

AIA-Pack FSH Sample Diluting Solution

AIA-Pack FSH Sample Diluting Solution: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

FSH Elisa

For the Quantitative Determination of Follicle Stimulating Hormone Concentration in Human Serum by a Microplate Enzyme Immunoassay, Colorimetric.

Radioimmunoassay, Follicle-Stimulating Hormone

FSH AccuLite Clia Test System – 96 Wells

Catalogue number 475-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

Immulite 2000 FSH Kit Domestic 200t

Catalogue number 10901852, listed by Siemens Healthcare Diagnostics Products GmbH, Germany, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

FSH, hCG, LH & PRLs Vast AccuBind Elisa Test System – 960 Wells

3 catalogue numbers from 8325-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

Lumipulse G FSH-N Immunoreaction Cartridges

Catalogue number 235218, listed by Fujirebio Inc., Japan, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

Architect

ARCHITECT FSH Reagent Kit (100T)

Radioimmunoassay, Follicle-Stimulating Hormone

Elecsys FSH

5 catalogue numbers from 09745840190, listed by Roche Diagnostics Gmbh, Germany, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

AIA-Pack FSH Calibrator Set

AIA-Pack FSH Calibrator Set: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, Follicle-Stimulating Hormone. 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Follicle-Stimulating Hormone

Immulite® 2000 Systems FSH

FSH - IMMULITE - RGT - 200 Tests

Radioimmunoassay, Follicle-Stimulating Hormone

Advia Centaur® FSH

FSH - CENTAUR - RGT - 500 tests

Radioimmunoassay, Follicle-Stimulating Hormone

Access hFSH

The Access hFSH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of follicle stimulating hormone (FSH) levels in human serum and plasma…

Radioimmunoassay, Follicle-Stimulating Hormone

Atellica IM FSH

Follicle Stimulating Hormone (FSH) - Atellica IM - RGT 950T

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