DBC Estradiol Elisa

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

Registry build 21.09.26
5manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jilin (1), Hebei (1), Guangdong (1).

Chinese manufacturers registered for FDA product code CHP
Manufacturer City Province Registered as Device types
Dirui Industrial Co., Ltd. Changchun Jilin Contract manufacturer 84
Shijiazhuang Hipro Biotechnology Co., Ltd. Shijiazhuang Hebei Manufacturer 22
Shenzhen Yhlo Biotech Co., Ltd. Shenzhen Guangdong Manufacturer 19
Getein Biotech, Inc. Nanjing Jiangsu Manufacturer 19
Beijing Hotgen Biotech Co., Ltd. Beijing Beijing Manufacturer 13

Record

Regulatory record for DBC Estradiol Elisa
Listed by Diagnostics Biochem Canada, Inc., Canada
FDA product code CHP
Device type Radioimmunoassay, Estradiol
Device class Class 1
Regulation 21 CFR 862.1260
Establishment Manufacturer
Premarket notification Exempt
Record published 2022-11-15

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Storage Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for DBC Estradiol Elisa
Catalogue number Size Status
CAN-E-430 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Salimetrics Salimetrics LLC. 5
MP Biomedicals LLC Mp Biomedicals, LLC 4
17beta-Estradiol Saliva Luminescence Immunoassay IBL International Gmbh 4
Elecsys Estradiol III Roche Diagnostics Gmbh 3
Alinity Abbott Ireland 3
Advia Centaur® eE2 Siemens Healthcare Diagnostics Inc 3
Architect Abbott Ireland 3
Atellica IM eE2 Siemens Healthcare Diagnostics Inc 3
Pantex Pantex 2
Estradiol Sensitive Elisa DRG Instruments Gesellschaft mit beschränkter Haftung 2
Salivary Estradiol Elisa DRG Instruments Gesellschaft mit beschränkter Haftung 2
Ultrasensitive Estradiol Elisa American Laboratory Products Company 2

Showing 12 of 58. All products under Radioimmunoassay, Estradiol

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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