Ast AS2800
Ast AS2800 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 05055273200461), 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 | Number05055273200461 | Date9 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK923505 | Date16 Nov 1992 | StatusActive |
Official records
- AccessGUDID record 05055273200461
- FDA 510(k) database K923505
Across registries
- FDA 510(k) K923505 decided 16 Nov 1992 Active
- FDA GUDID UDI-DI 05055273200461 listed 9 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K923505
- Listed FDA GUDID 05055273200461
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- Withdrawn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
- AS2800
- Primary DI / UDI-DI
- 05055273200461
- 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).
- AST S.C.E. (GOT) by J. D. Assoc.
- REAGENT SET, U.V. ENZMATIC KINETIC, SGOT by Medical Analysis Systems, Inc.
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- MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT by Diagnostic Chemicals, Ltd. (Usa)
- SPIN CHEM REAGENT, DETERMINATION OF AST by Smithkline Diagnostics, Inc.
- BIOBASE R1:100mL×1 R2:25mL×1 R1:100mL×1 R2:25mL×1 by Biobase Biodustry(Shandong) Co.,Ltd.
- AST(SGOT) IN VITRO DIAG. REAGENT SET by POINTE SCIENTIFIC, INC.
- ASPARTATE AMINOTRANFERASE (AST) by American Monitor Corp.
- WAKO (TM) AUTOKIT GOT TEST by Wako Chemicals USA, Inc.
- Atellica CH AST 11097607 by Siemens Healthcare Diagnostics Inc.