AccuDiag™

AccuDiag™ Anti-Phospholipid Screen IgG/IgM ELISA

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Jilin.

Chinese manufacturers registered for FDA product code JNT
Manufacturer City Province Registered as Device types
Dirui Industrial Co., Ltd. Changchun Jilin Contract manufacturer 84

Record

Regulatory record for AccuDiag™
Listed by Diagnostic Automation, Inc.
FDA product code JNT
Device type Chromatographic, Phospholipids
Device class Class 1
Regulation 21 CFR 862.1575
Record published 2024-05-10

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
DACD2560-6 96 tests In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Rabbit Monoclonal Anti-Human BOB.1 Epitomics Inc. 1

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