JAS Diagnostics A1CC1-0.5
JAS Diagnostics A1CC1-0.5 is a device made by Drew Scientific, Ltd., listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00817274021743), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817274021743 | Date9 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00817274021743
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- JAS Diagnostics
- Generic name
- Multiple coagulation marker IVD, control
- Model / reference
- A1CC1-0.5
- Primary DI / UDI-DI
- 00817274021743
- GMDN term
- Multiple coagulation marker IVD, control
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Multiple coagulation factor IVD, control.
- 550-11 by MEDTRONIC, INC.
- STA® - System Control N + P 00678 by DIAGNOSTICA STAGO
- K-ASSAY® Factor XIII Control K135C-10M by KAMIYA BIOMEDICAL COMPANY, LLC
- BIOPHEN NORMAL CONTROL PLASMA 223201 by HYPHEN BIOMED
- STA® - Coag Control (N + ABN) PLUS 00677 by DIAGNOSTICA STAGO
- COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2) CG5022 by Randox Laboratories, Ltd.
- ROTEM® ROTROL P 503-25-US, 503-25 by Tem Innovations GmbH
- Dade® Ci-Trol® Heparin Control, High 10445716 B4224-60 by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- PlasmaCon LA 150-201 by r2 Diagnostics Inc.