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LOOKEE® AscleTrack™ Urine Microalbumin (MAU) Test Strip A802

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 Number06972164410022 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  • Withdrawn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™ Urine Microalbumin (MAU) Test Strip
Generic Name
Microalbumin IVD, kit, nephelometry/turbidimetry
Model / Reference
A802
Primary DI / UDI-DI
06972164410022
FDA Product Code
JIR
GMDN Term
Microalbumin IVD, kit, nephelometry/turbidimetry
Device Class
Class I
Regulation Number
862.1645
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