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JAS Diagnostics XL-ALT2-40

by Drew Scientific, Ltd.

JAS Diagnostics XL-ALT2-40 is a Class I device made by Drew Scientific, Ltd., listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00817274020746), 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

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817274020746 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: 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  • Withdrawn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
JAS Diagnostics
Generic name
Alanine aminotransferase (ALT) IVD, kit, spectrophotometry
Model / reference
XL-ALT2-40
Primary DI / UDI-DI
00817274020746
FDA product code
CKA
GMDN term
Alanine aminotransferase (ALT) IVD, kit, spectrophotometry
Device class
Class I
Regulation number
862.1030
GUDID distribution status
In Commercial Distribution

Related devices

Category: Alanine aminotransferase (ALT) IVD, kit, spectrophotometry

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Properties

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