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PIFA® Heparin/PF4 Rapid Assay 4036025

by Akers Biosciences, 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00708872615123 UDI-DI Date24 Sep 2016ListedStatusListed 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  • Withdrawn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
PIFA® Heparin/PF4 Rapid Assay
Generic Name
Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinical
Model / Ref / Catalog
4036025
Primary DI / UDI-DI
00708872615123
FDA Product Code
LCO
GMDN Term
Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinical
Device Class
Class II
Regulation Number
864.7695
GUDID distribution status
In Commercial Distribution

Related devices

Category: Platelet factor 4-heparin complex total antibody IVD, kit, rapid agglutination, clinical

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Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No