Skip to content

HemaPrompt FG HPFG

by Aerscher, 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 Number00693501000152 UDI-DI Date5 Aug 2016ListedStatusListed 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  • Withdrawn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
HemaPrompt FG
Generic Name
Biological fluid occult blood screening IVD, kit, rapid colorimetric, clinical
Model / Reference
HPFG
Primary DI / UDI-DI
00693501000152
510(k) Number
FDA Product Code
KHE
GMDN Term
Biological fluid occult blood screening IVD, kit, rapid colorimetric, clinical
Device Class
Class II
Regulation Number
864.6550
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Category: Biological fluid occult blood screening IVD, kit, rapid colorimetric, clinical

Other devices from Aerscher, Inc.

Properties

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

Other properties (10)

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