Dhea Elisa

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

Registry build 21.09.26
3manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

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

Chinese manufacturers registered for FDA product code JKC
Manufacturer City Province Registered as Device types
Dirui Industrial Co., Ltd. Changchun Jilin Contract manufacturer 84
Biobase Biodustry(Shandong)Co., Ltd. Jinan Shandong Manufacturer 70
Shenzhen Yhlo Biotech Co., Ltd. Shenzhen Guangdong Manufacturer 19

Record

Regulatory record for Dhea Elisa
Listed by DRG International, Inc., United States
FDA product code JKC
Device type Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Device class Class 1
Regulation 21 CFR 862.1245
Establishment Repacker / relabeller, Complaint-file establishment
Premarket notification Exempt
Record published 2023-08-24

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Dhea Elisa
Catalogue number Size Status
EIA-3415 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Dhea-S DRG Instruments Gesellschaft mit beschränkter Haftung 3
Atellica IM Dheas Siemens Healthcare Diagnostics Inc 3
Dhea-S Elisa DRG International, Inc. 2
Dhea DRG Instruments Gesellschaft mit beschränkter Haftung 2
Dhea Elisa DRG Instruments Gesellschaft mit beschränkter Haftung 2
Dehydroepiandrosterone (Dhea) Elisa American Laboratory Products Company 2
Elecsys Dhea-S Roche Diagnostics Gmbh 2
Architect Abbott Medical 2
Dhea-S Elisa DRG Instruments Gesellschaft mit beschränkter Haftung 2
iFlash-DHEA-S Shenzhen Yhlo Biotech Co., Ltd. 1
Dhea-S AccuBind Elisa Test System – 96 Wells Monobind, Inc. 1
ST AIA-Pack Dhea-S Sample Diluting Solution Tosoh Corp. 1

Showing 12 of 45. All products under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

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