Alt / BS480 ALT480

Alt / BS480 ALT480 is a Class I device made by Medtest DX, listed in FDA GUDID since 27 Sep 2016 (UDI-DI 00817439020154), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00817439020154 UDI-DI	Date27 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00817439020154

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Alt / BS480
Generic name: Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
Model / Ref / Catalog: ALT480

Primary DI / UDI-DI: 00817439020154
FDA product code: CKA
GMDN term: Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

Device class: Class I
Regulation number: 862.1030
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Convenience kit
Premarket exempt
Lot / batch number
Expiration date

Other properties (10, all answered No)