Radioimmunoassay, Dehydroepiandrosterone (Free and Sulfate)

Who Makes This Device Type in China?

3 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Jilin and Shandong.

Biobase Biodustry(Shandong)Co., Ltd. Shandong
Dirui Industrial Co., Ltd. Jilin, contract manufacturer
Shenzhen Yhlo Biotech Co., Ltd. Guangdong

How Is JKC Classified?

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) is FDA product code JKC, Class 1, 21 CFR 862.1245.

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 7 recalls under this product code since 2010. None was by a company in China. The root causes the FDA records most often are Device Design (3), No Marketing Application (2) and Process control (1).

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

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea AccuBind Elisa Test System – 96 Wells

Catalogue number 7425-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Advia Centaur® Dheas

DHEA-S - CENTAUR - RGT - 50 tests

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Atellica IM DHEAS2 (REF) 500t

Atellica IM DHEAS2 (REF) 500T Atellica IM-REF Reagent (REF RGT)

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Access Dhea-S

The Access DHEA-S assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Dehydroepiandrosterone sulfate levels in human serum and plasma using…

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dehydroepiandrosterone Sulfate (Dhea-S) Elisa

Catalogue number EQ 6155-9601, listed by Euroimmun Medizinische Labordiagnostika AG, Germany, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea AccuLite Clia Test System – 192 Wells

Catalogue number 7475-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Immulite®/Immulite® 1000 Systems DHS DHEA-SO4

DHEA-S - IMMULITE - RGT - 100 Tests

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea-Elisa

Catalogue number KAPDB490, listed by Diasource Immunoassays, S.A., United States, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Atellica IM DHEAS2 100t KIT

Atellica IM DHEASII 100T KIT

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

DHEA-S-7 RIA

Catalogue number DSL2700, listed by Immunotech s.r.o., Czechia, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea-S AccuLite Clia Test System – 96 Wells

Catalogue number 5175-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

ST AIA-Pack Dhea-S

ST AIA-Pack Dhea-S: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea AccuLite Clia Test System – 96 Wells

Catalogue number 7475-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea AccuBind Elisa Test System – 192 Wells

Catalogue number 7425-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea-S Elisa

The DRG DHEA S ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of DHEA-S in serum and plasma

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea-S Elisa

The DHEA-S ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of DHEA-S in serum and plasma.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dehydroepiandrosterone (Dhea) Elisa

Catalogue number EQ 6154-9601-1, listed by Euroimmun Medizinische Labordiagnostika AG, Germany, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Immulite 2000 Dheas Kit Domestic 200t

Catalogue number 10901849, listed by Siemens Healthcare Diagnostics Products GmbH, Germany, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

DBC Dehydroepiandrosterone Sulfate (Dheas) Elisa

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

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea-S Elisa

DHEA-S ELISA - 96 Determinations

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea Elisa

DHEA ELISA - 96 Determinations

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea Elisa

The DRG DHEA ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of DHEA in serum or citrate plasma.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea-S AccuBind Elisa Test System – 192 Wells

Catalogue number 5125-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Architect

ARCHITECT DHEA-S Reagent Kit

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Immulite® 2000 Systems DHS DHEA-SO4

DHEA-S - IMMULITE - RGT - 200 Tests

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea-S

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

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dehydroepiandrosterone Sulfate (Dhea-S) Elisa

Intended for the direct quantitative determination of DHEA-S by enzyme immunoassay in human serum. For in vitro diagnostic use.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

DBC Dehydroepiandrosterone (Dhea) Elisa

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

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea-S-RIA-CT

Catalogue number KIP0481, listed by Diasource Immunoassays, S.A., United States, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Elecsys Dhea-S

2 catalogue numbers from 3000087122, listed by Roche Diagnostics Gmbh, Germany, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

MP Biomedicals LLC

Immuchem Coated Tube Dehydroepiandrosterone-Sulfate (Dhea-S) 125I RIA 100 Tube KIT

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Alinity

Alinity i DHEA-S Reagent Kit 200 Tests

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Atellica IM Dheas

DHEAS - Atellica IM - RGT 250T

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Access Dhea-S Calibrators

The Access DHEA-S Calibrators are intended to calibrate the Access DHEA-S assay for the quantitative determination of Dehydroepiandrosterone sulfate levels in human serum and plasma using…

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea-S AccuLite Clia Test System – 192 Wells

Catalogue number 5175-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Ionify Steroids 2

Ionify DHEA Ionify DHEA-S Ionify 17-Hydroxyprogesterone Ionify Progesterone

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea

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

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Immulite®/Immulite® 1000 Systems DHS DHEASO4 Sample Diluent

DHEA-S Sample Diluent - IMMULITE - 1x25mL

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

ST AIA-Pack Dhea-S Sample Diluting Solution

ST AIA-Pack Dhea-S Sample Diluting Solution: 1 catalogue number listed by Tosoh Corp., Japan, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea-S AccuBind Elisa Test System – 96 Wells

Catalogue number 5125-300, listed by Monobind, Inc., United States, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dehydroepiandrosterone (Dhea) Elisa

The DHEA ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of dehydroepiandrosterone (DHEA) in human serum and citrate plasma. For in vitro diagnostic use.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea Elisa

The DRG DHEA ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of [DHEA in serum or citrate plasma.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea

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

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

iFlash-DHEA-S

Catalogue number C86033, listed by Shenzhen Yhlo Biotech Co., Ltd., China, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea-S

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

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Dhea-S Elisa

The DRG DHEA S ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of DHEA-S in serum and plasma

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