Radioimmunoassay, Progesterone

Who Makes This Device Type in China?

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

Beijing Hotgen Biotech Co., Ltd. Beijing
Getein Biotech, Inc. Jiangsu
Shenzhen Yhlo Biotech Co., Ltd. Guangdong
Shijiazhuang Hipro Biotechnology Co., Ltd. Hebei

How Is JLS Classified?

Radioimmunoassay, Progesterone is FDA product code JLS, Class 1, 21 CFR 862.1620.

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 21 recalls under this product code since 2002. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (6), Process control (4) and Device Design (3).

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

Radioimmunoassay, Progesterone

Progesterone Elisa

Intended for the direct quantitative determination of Progesterone by enzyme immunoassay using human serum. For in vitro diagnostic use.

Radioimmunoassay, Progesterone

Atellica IM Prge MCM

Progesterone (PRGE) Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL

Radioimmunoassay, Progesterone

IDS-iSYS 17-OH Progesterone

Catalogue number IS-5100, listed by Immunodiagnostic Systems Ltd., United Kingdom, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Progesterone

Progesterone AccuLite Clia Test System – 192 Wells

Catalogue number 4875-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Progesterone

Immulite 2000 Progesterone Kit Domestic 600t

Catalogue number 10901874, listed by Siemens Healthcare Diagnostics Products GmbH, Germany, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Progesterone

Advia Centaur® Prge +e

Progesterone - CENTAUR - RGT - 250 tests

Radioimmunoassay, Progesterone

Salivary Progesterone HS Elisa

Catalogue number SLV-5911, listed by DRG International, Inc., United States, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Progesterone

Progesterone AccuBind Elisa Test System – 96 Wells

Catalogue number 4825-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Progesterone

iFlash-Progesterone

Catalogue number C86030, listed by Shenzhen Yhlo Biotech Co., Ltd., China, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Progesterone

Salivary Progesterone Elisa

Catalogue number SLV-2931, listed by DRG International, Inc., United States, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Progesterone

Sali-Tubes 500

Sampling tubes for collection of saliva samples to be used in the DRG Salivary Immunoassays

Radioimmunoassay, Progesterone

Progesterone (Serum)

The DRG Progesterone Chemiluminescence Immunoassay Kit provides materials for the quantitative determination of Progesterone in serum and plasma.

Radioimmunoassay, Progesterone

Progesterone

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

Radioimmunoassay, Progesterone

Access Progesterone II

The Access Progesterone II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of progesterone levels in human serum and plasma (lithium…

Radioimmunoassay, Progesterone

Atellica IM Prge

Progesterone (PRGE) - Atellica IM - RGT 450T

Radioimmunoassay, Progesterone

AccuDiag™ Progesterone Elisa

AccuDiag™ Progesterone ELISA A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of progesterone in a clinical…

Radioimmunoassay, Progesterone

Immulite® 2000 Systems PRG Progesterone

Progesterone - IMMULITE - RGT - 600 Tests

Radioimmunoassay, Progesterone

Lumipulse G Progesterone-N Immunoreaction Cartridges

Catalogue number 235256, listed by Fujirebio Inc., Japan, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Progesterone

Progesterone

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

Radioimmunoassay, Progesterone

Deltec

Catalogue number 21-2895-01, listed by ICU Medical, Inc, United States, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Progesterone

Progesterone (Serum) Elisa

The DRG Progesterone Chemiluminescence Immunoassay Kit provides materials for the quantitative determination of Progesterone in serum and plasma.

Radioimmunoassay, Progesterone

Advia Centaur® Immunoassay Systems Prge MCM

Progesterone Master Curve Material SET - CENTAUR – CONS

Radioimmunoassay, Progesterone

ST AIA-Pack Prog III Sample Diluting Solution

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

Radioimmunoassay, Progesterone

Prog Elisa

Catalogue number KAP1451, listed by Diasource Immunoassays, S.A., United States, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Progesterone

SaliCaps

SaliCaps - 500 Tubes

Radioimmunoassay, Progesterone

Access Progesterone II Sample Diluent

The Access Progesterone II Sample Diluent is intended for use with the Access Progesterone II assay to dilute samples containing progesterone concentrations greater than the S5 calibrator…

Radioimmunoassay, Progesterone

Access Progesterone Calibrator S0

The Access Progesterone Calibrator S0 is intended for use with the Access Progesterone assay to dilute patient samples containing analyte concentrations greater than the analyte specific S5…

Radioimmunoassay, Progesterone

ST AIA-Pack Prog III

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

Radioimmunoassay, Progesterone

Progesterone AccuBind Elisa Test System – 192 Wells

Catalogue number 4825-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Progesterone

Immulite 2000 Progesterone Kit Domestic 200t

Catalogue number 10901873, listed by Siemens Healthcare Diagnostics Products GmbH, Germany, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Progesterone

Pantex

Salivary Progesterone Enzyme Immunoassay (1)

Radioimmunoassay, Progesterone

Prog-RIA-CT

Catalogue number KIP1458, listed by Diasource Immunoassays, S.A., United States, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Progesterone

Progesterone AccuLite Clia Test System – 96 Wells

Catalogue number 4875-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Progesterone

Progesterone Elisa

The DRG Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Progesterone in serum or plasma (EDTA, lithium heparin or citrate plasma)

Radioimmunoassay, Progesterone

Vidas® Progesterone

VIDAS ® Progesterone (PRG) assay is a quantitative IA intended for use on VIDAS family instrument in the determination of progesterone concentration in human serum or plasma.

Radioimmunoassay, Progesterone

Progesterone Luminescence Immunoassay

Progesterone Luminescence Immunoassy - 10 x 96 Determinations

Radioimmunoassay, Progesterone

Dimension Vista® Flex® Reagent Cartridge Prog

LOCI Progesterone Flex® reagent cartridge, 320 Tests

Radioimmunoassay, Progesterone

Salimetrics

Salivary Progesterone Enzyme Immunoassay Kit (25-pack)

Radioimmunoassay, Progesterone

Progesterone Elisa

The DRG Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Progesterone in serum or plasma (EDTA, lithium heparin or citrate plasma)

Radioimmunoassay, Progesterone

Access Progesterone

The Access Progesterone assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of progesterone levels in human serum using the Access Immunoassay…

Radioimmunoassay, Progesterone

Progest-US

Radioimmunometric assay kit for the quantitative determination of progesterone in human samples. Contain enough reagents for 100 tests. For in vitro diagnostic.

Radioimmunoassay, Progesterone

Architect

ARCHITECT PROGESTERONE REAGENT KIT 1 x 500

Radioimmunoassay, Progesterone

CL AIA-Pack Progesterone Test CUP

CL AIA-Pack Progesterone Test CUP: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Progesterone

Advia Centaur® Progesterone (Prge)

Progesterone (Ref) - CENTAUR - RGT - 250 tests

Radioimmunoassay, Progesterone

Salivary Progesterone HS Elisa

2 catalogue numbers from SLV-5911, listed by DRG Instruments Gesellschaft mit beschränkter Haftung, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Progesterone

ST-AIA-Pack Prog II Sample Diluting Solution

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

Radioimmunoassay, Progesterone

Advia Centaur® Prge

Progesterone - CENTAUR - RGT - 50 tests

Radioimmunoassay, Progesterone

Alinity

Alinity i Progesterone Reagent Kit 1000 Tests

Radioimmunoassay, Progesterone

MP Biomedicals LLC

Immuchem Double Antibody Progesterone 125I RIA 100 Tube KIT

Radioimmunoassay, Progesterone

DBC Progesterone Elisa

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

Radioimmunoassay, Progesterone

Sali-Tubes 100

Sampling tubes for collection of saliva samples to be used in the DRG Salivary Immunoassays

Radioimmunoassay, Progesterone

Immulite®/Immulite® 1000 Systems PRG Progesterone

Progesterone Sample Diluent - IMMULITE - CAL - 1x25mL

Radioimmunoassay, Progesterone

Elecsys Progesterone III

3 catalogue numbers from 07027699190, listed by Roche Diagnostics Gmbh, Germany, under Radioimmunoassay, Progesterone. 4 manufacturers in China are registered for this product code.

Radioimmunoassay, Progesterone

Vitros

VITROS Immunodiagnostic Products Progesterone 2 Reagent Pack

Radioimmunoassay, Progesterone

Salivary Progesterone Elisa

2 catalogue numbers from SLV-2931, listed by DRG Instruments Gesellschaft mit beschränkter Haftung, under Radioimmunoassay, Progesterone. 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