Ast AS1202
Ast AS1202 is a Class II device made by Randox Laboratories, Ltd., cleared under FDA 510(k) K923505 on 16 Nov 1992 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 05055273200416), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05055273200416 | Date9 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK923505 | Date16 Nov 1992 | StatusActive |
Official records
- AccessGUDID record 05055273200416
- FDA 510(k) database K923505
Across registries
- FDA 510(k) K923505 decided 16 Nov 1992 Active
- FDA GUDID UDI-DI 05055273200416 listed 9 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K923505
- Listed FDA GUDID 05055273200416
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ast
- Generic name
- Aspartate aminotransferase (AST) isoenzyme IVD, reagent
- Model / Ref / Catalog
- AS1202
- Primary DI / UDI-DI
- 05055273200416
- 510(k) Number
- FDA product code
- CIT
- GMDN term
- Aspartate aminotransferase (AST) isoenzyme IVD, reagent
- Device class
- Class II
- Regulation number
- 862.1100
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot).
- ROCHE REAGENT FOR AST by Roche Diagnostic Systems, Inc.
- CLINISTAT SGOT (AST) REAGENT TEST by Heraeus Kulzer, Inc.
- ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC) by Diagnostic Chemicals, Ltd. (Usa)
- ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS by Diasys Diagnostics Systems GmbH
- BIOBASE R1:48mL×2 R2:12mL×2 R1:48mL×2 R2:12mL×2 by Biobase Biodustry(Shandong) Co.,Ltd.
- MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD by Heraeus Kulzer, Inc.
- ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42 by Em Diagnostic Systems, Inc.
- COBAS REAGENT FOR AST (SGOT) by Roche Analytical Instruments, Inc.
- BIOBASE R1:40mL×4 R2:20mL×2 R1:40mL×4 R2:20mL×2 by Biobase Biodustry(Shandong) Co.,Ltd.
- COULTER DART AST (GOT) REAGENT by Coulter Electronics, Inc.