Genchem™ Ast/Sgot Gen-Ast R1

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00851445007051 UDI-DI	Date19 Sep 2016Listed	StatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Genchem™ Ast/Sgot
Generic Name: Aspartate aminotransferase (AST) isoenzyme IVD, reagent
Model / Ref / Catalog: GEN-AST R1

Primary DI / UDI-DI: 00851445007051
FDA Product Code: CIT
GMDN Term: Aspartate aminotransferase (AST) isoenzyme IVD, reagent

Device Class: Class II
Regulation Number: 862.1100
GUDID distribution status: Not in Commercial Distribution

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Properties

Single Use
Prescription Use
Lot / Batch Number
Expiration Date

Other properties (10)

Sterile: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Manufacturing Date: No