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hema-screen SPECIFIC BUF17-25

by Immunostics

hema-screen SPECIFIC BUF17-25 is a Class II device made by Immunostics, listed in FDA GUDID since 21 Sep 2016 (UDI-DI 10722355001156), registry data as of 8 Nov 2026.

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

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10722355001156 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
hema-screen SPECIFIC
Generic name
Faecal occult blood IVD, reagent
Model / reference
BUF17-25
Primary DI / UDI-DI
10722355001156
FDA product code
KHE
GMDN term
Faecal occult blood IVD, reagent
Device class
Class II
Regulation number
864.6550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Faecal occult blood IVD, reagent

Similar devices

Other devices filed under FDA product code KHE (REAGENT, OCCULT BLOOD).

Other devices from Immunostics

See all devices from Immunostics →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)