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Heparin/PF4 Antibody Serum Panel 4036028

by Akers Biosciences, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00708872000011 UDI-DI Date5 Mar 2018ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Heparin/PF4 Antibody Serum Panel
Generic Name
Platelet factor 4-heparin complex antibody IVD, control
Model / Ref / Catalog
4036028
Primary DI / UDI-DI
00708872000011
510(k) Number
FDA Product Code
GGN
GMDN Term
Platelet factor 4-heparin complex antibody IVD, control
Device Class
Class II
Regulation Number
864.5425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Platelet factor 4-heparin complex antibody IVD, control

Cleared under the same submission (K052697)

Other devices from Akers Biosciences, Inc.

See all devices from Akers Biosciences, Inc. →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

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