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LOOKEE® AscleTrack™ Heart-type Fatty Acid-Binding Protein (H-FABP) Test Strip A801

by Kunming Lianen Biotechnology Co., LTD

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

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06972164410039 UDI-DI Date26 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
LOOKEE® AscleTrack™ Heart-type Fatty Acid-Binding Protein (H-FABP) Test Strip
Generic Name
Non-esterified fatty acid IVD, reagent
Model / Reference
A801
Primary DI / UDI-DI
06972164410039
FDA Product Code
JLH
GMDN Term
Non-esterified fatty acid IVD, reagent
Device Class
Class I
Regulation Number
862.1290
GUDID distribution status
In Commercial Distribution

Other devices from Kunming Lianen Biotechnology Co., LTD

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No