AccuDiag ™

AccuDiag ™T3 ELISA is intended for the quantitative determination of Triiodothyronine (T3) concentration in human serum.

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 CDP
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 AccuDiag ™
Listed by Diagnostic Automation, Inc.
FDA product code CDP
Device type Radioimmunoassay, Total Triiodothyronine
Device class Class 2
Regulation 21 CFR 862.1710
Record published 2023-06-14

Specifications

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

Catalogue Numbers

Catalogue numbers for AccuDiag ™
Catalogue number Size Status
DACD3144-18 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Architect Abbott Ireland 9
Alinity Abbott Ireland 5
Elecsys FT3 III Roche Diagnostics Gmbh 4
Elecsys T3 Roche Diagnostics Gmbh 4
Advia Centaur® T3 Siemens Healthcare Diagnostics Inc 3
Free Triiodothyronine (fT3) Elisa DRG Instruments Gesellschaft mit beschränkter Haftung 3
Total T3 125I RIA Kit Mp Biomedicals, LLC 3
Atellica IM FT3 Siemens Healthcare Diagnostics Inc 3
Vitros Ortho-Clinical Diagnostics, Inc. 3
Atellica IM T3 Siemens Healthcare Diagnostics Inc 3
Advia Centaur® FT3 Siemens Healthcare Diagnostics Inc 3
Free Triiodothyronine (fT3) Elisa DRG International, Inc. 3

Showing 12 of 78. All products under Radioimmunoassay, Total Triiodothyronine

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