Radioimmunoassay, Prolactin (Lactogen)

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.

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
Shijiazhuang Hipro Biotechnology Co., Ltd. Hebei

What Is FDA Product Code CFT?

Radioimmunoassay, Prolactin (Lactogen) is FDA product code CFT, Class 1, 21 CFR 862.1625.

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 Do the Recalls Say?

The FDA has recorded 6 recalls under this product code since 2009. None was by a company in China. The root causes the FDA records most often are Device Design (3), Nonconforming Material/Component (1) and Equipment maintenance (1).

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

Radioimmunoassay, Prolactin (Lactogen)

Immulite®/Immulite® 1000 Systems PRL Prolactin Sample Diluent

Prolactin Sample Diluent - IMMULITE - 1x25mL

Radioimmunoassay, Prolactin (Lactogen)

Advia Centaur® Prolactin (PRL)

Prolactin (Ref) - CENTAUR - RGT - 250 tests

Radioimmunoassay, Prolactin (Lactogen)

ST AIA-Pack PRL

ST AIA-Pack PRL: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

PRLs AccuBind Elisa Test System – 192 Wells

Catalogue number 4425-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

Prolactin Elisa

The DRG Prolactin ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Prolactin in serum.

Radioimmunoassay, Prolactin (Lactogen)

PRLs AccuBind Elisa Test System – 96 Wells

Catalogue number 4425-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

AIA-Pack PRL Sample Diluting Solution

AIA-Pack PRL Sample Diluting Solution: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

PRL-Irma

Catalogue number KIP1441, listed by Diasource Immunoassays, S.A., United States, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

Immulite 2000 Prolactin Kit Domestic 200t

Catalogue number 10901868, listed by Siemens Healthcare Diagnostics Products GmbH, Germany, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

AIA-Pack PRL Calibrator SET

AIA-Pack PRL Calibrator SET: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

PRL AccuLite Clia Test System – 192 Wells

Catalogue number 775-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

PRLs AccuLite Clia Test System – 96 Wells

Catalogue number 4475-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

Dimension Vista® Flex® Reagent Cartridge PRL

LOCI Prolactin Flex® reagent cartridge, 200 tests

Radioimmunoassay, Prolactin (Lactogen)

iFlash-Prolactin

Catalogue number C86013, listed by Shenzhen Yhlo Biotech Co., Ltd., China, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

PRL AccuLite Clia Test System – 96 Wells

Catalogue number 775-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

PRL AccuBind Elisa Test System – 192 Wells

Catalogue number 725-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

Access Prolactin

The Access Prolactin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of prolactin (PRL) levels in human serum and plasma (heparin) using…

Radioimmunoassay, Prolactin (Lactogen)

Lumipulse G Prolactin Immunoreaction Cartridges

Catalogue number 235195, listed by Fujirebio Inc., Japan, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

DBC Prolactin Elisa

For the quantitative determination of Prolactin in human serum by an enzyme immunoassay. For in vitro diagnostic use.

Radioimmunoassay, Prolactin (Lactogen)

Prolactin Elisa

The Prolactin ELISA is an enzyme immunoassay for the quantitative determination of Prolactin in human serum. For in vitro diagnostic use in the United States of America. For research use…

Radioimmunoassay, Prolactin (Lactogen)

AccuDiag™ Prolactin (PRL) Elisa

AccuDiag™ Prolactin (PRL) ELISA A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of prolactin in a clinical…

Radioimmunoassay, Prolactin (Lactogen)

Immulite 2000 Prolactin Kit Domestic 600t

Catalogue number 10901869, listed by Siemens Healthcare Diagnostics Products GmbH, Germany, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

Prolactin

The DRG:Hybrid-XL Prolactin is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Prolactin in serum.

Radioimmunoassay, Prolactin (Lactogen)

Vitros

VITROS Immunodiagnostic Products Prolactin Reagent Pack

Radioimmunoassay, Prolactin (Lactogen)

CL AIA-Pack Prolactin II Test CUP

CL AIA-Pack Prolactin II Test CUP: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

Access Prolactin Calibrators

The Access Prolactin Calibrators are intended to calibrate the Access Prolactin assay for the quantitative determination of prolactin (PRL) levels in human serum and plasma (heparin) using…

Radioimmunoassay, Prolactin (Lactogen)

PRLs AccuLite Clia Test System – 192 Wells

Catalogue number 4475-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

Prolactin

The DRG:Hybrid-XL Prolactin is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Prolactin in serum.

Radioimmunoassay, Prolactin (Lactogen)

Atellica IM PRL

Prolactin (PRL) - Atellica IM - RGT 250

Radioimmunoassay, Prolactin (Lactogen)

Prolactin Elisa

For the quantitative determination of Prolactin in human serum by an enzyme immunoassay.

Radioimmunoassay, Prolactin (Lactogen)

Immulite® 2000 Systems PRL Prolactin

Prolactin - IMMULITE - RGT - 600 Tests

Radioimmunoassay, Prolactin (Lactogen)

Papp-A AccuBind Elisa Test System – 96 Wells

Catalogue number 12625-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

Alinity

Alinity i Prolactin Reagent Kit 1200 Tests

Radioimmunoassay, Prolactin (Lactogen)

Prolactin Elisa

The Prolactin ELISA is intended for the quantitative determination of prolactin in human serum. The assay is useful in the diagnosis and treatment of disorders of the anterior pituitary and…

Radioimmunoassay, Prolactin (Lactogen)

Pointe Scientific, Inc.

The Prolactin ELISA is intended for the quantitative determination of prolactin in human serum. This assay is useful in the diagnosis and treatment of disorders of the anterior pituitary…

Radioimmunoassay, Prolactin (Lactogen)

Vidas® Prolactin

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

Radioimmunoassay, Prolactin (Lactogen)

Immulite® 2000 Systems PRL Prolactin Sample Diluent

Prolactin Sample Diluent - IMMULITE - 1x25mL

Radioimmunoassay, Prolactin (Lactogen)

Elecsys Prolactin II

3 catalogue numbers from 09755764190, listed by Roche Diagnostics Gmbh, Germany, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

Monobind AccuBind PRL Elisa Kit – 96 Wells

Catalogue number 725-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Prolactin (Lactogen). 6 manufacturers in China are registered for this product code.

Radioimmunoassay, Prolactin (Lactogen)

Architect

ARCHITECT Prolactin Reagent Kit (100T)

Radioimmunoassay, Prolactin (Lactogen)

Advia Centaur® PRL

Prolactin - CENTAUR - RGT - 250 tests

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