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Myeloperoxidase (P) NPAI023T40

by Biocare Medical, LLC

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 Number00847627041937 UDI-DI Date6 Jan 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  • Withdrawn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
Myeloperoxidase (P)
Generic Name
Leukocyte myeloperoxidase (MPO) IVD, antibody
Model / Reference
NPAI023T40
Primary DI / UDI-DI
00847627041937
FDA Product Code
NJT
GMDN Term
Leukocyte myeloperoxidase (MPO) IVD, antibody
Device Class
Class I
Regulation Number
864.1860
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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