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Ast / BS480 AST480

by Medtest DX

Ast / BS480 AST480 is a Class II device made by Medtest DX, listed in FDA GUDID since 27 Sep 2016 (UDI-DI 00817439020222), not in commercial distribution (GUDID) as of 22 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817439020222 UDI-DI Date27 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Ast / BS480
Generic name
Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Model / Ref / Catalog
AST480
Description
For the quantitative determination of Aspartate Aminotransferase (AST) in human serum using the Mindray BS-480 analyzer. 5 x 60 ml, 5 x 15 ml
Primary DI / UDI-DI
00817439020222
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).

Other devices from Medtest DX

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Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)