AST / Polychem 180 AST505
by Medtest DX
AST / Polychem 180 AST505 is a Class II device made by Medtest DX, listed in FDA GUDID since 27 Sep 2016 (UDI-DI 00817439020239), not in commercial distribution (GUDID) 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 | Number00817439020239 | Date27 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00817439020239
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- AST / Polychem 180
- Generic name
- Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
- Model / Ref / Catalog
- AST505
- Description
- For the quantitative determination of Aspartate Aminotransferase (AST) in human serum using the Poly-Chem 180 analyzer. 6 x 50 ml, 3 x 20 ml
- Primary DI / UDI-DI
- 00817439020239
- FDA product code
- CIT
- GMDN term
- Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
- Device class
- Class II
- Regulation number
- 862.1100
- GUDID distribution status
- Not in Commercial Distribution
Similar devices
Other devices filed under FDA product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot).
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- REFLOTRON(R) AST (GOT) by Boehringer Mannheim Corp.
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- Ast(Got) (Aspartate Aminotransferase) Reagent by Trace Scientific, Ltd.
- BIOBASE R1:64mL×6 R2:48mL×2 R1:64mL×6 R2:48mL×2 by Biobase Biodustry(Shandong) Co.,Ltd.