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Amino Acid Qc 1 B Amin QC1B P F Nhi

by UTAK Laboratories Inc.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB800AMINQC1BPFNHI0 UDI-DI Date1 Apr 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  • Withdrawn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
Amino Acid Qc 1 B
Generic Name
Multiple-type clinical chemistry analyte profile IVD, control
Model / Ref / Catalog
AMIN QC1B P F NHI
Primary DI / UDI-DI
B800AMINQC1BPFNHI0
FDA Product Code
LAS
GMDN Term
Multiple-type clinical chemistry analyte profile IVD, control
Device Class
Class I
Regulation Number
862.3280
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 1 Milliliter

Other devices from UTAK Laboratories Inc.

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Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

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