hema-screen ER HSTRER-100
by Immunostics
hema-screen ER HSTRER-100 is a Class II device made by Immunostics, listed in FDA GUDID since 23 Sep 2016 (UDI-DI 10722355002542), registry data as of 8 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10722355002542 | Date23 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 10722355002542
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- hema-screen ER
- Generic name
- Faecal occult blood IVD, kit, rapid colorimetric, clinical
- Model / reference
- HSTRER-100
- Primary DI / UDI-DI
- 10722355002542
- FDA product code
- KHE
- GMDN term
- Faecal occult blood IVD, kit, rapid colorimetric, clinical
- Device class
- Class II
- Regulation number
- 864.6550
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code KHE (REAGENT, OCCULT BLOOD).
- UROPAPER EIKEN 8 by Syn-Kit, Inc.
- FE-CULT PLUS by Gamma Biologicals, Inc.
- INSTACCULT by Medtek Diagnostics, LLC
- OCCULT-ALERT by Beta Med Pharmaceuticals, Inc.
- INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST by Alfa Scientific Designs, Inc.
- HEMAPROMPT by AERSCHER DIAGNOSTICS
- !NSURE FECAL OCCULT BLOOD TEST by ENTERIX INC.
- HEMO FEC by Boehringer Mannheim Corp.
- HEMOCCULT SENSITIVE TEST by Smithkline Diagnostics, Inc.
- CARE Fecal Occult Blood Test, Model KT313 by Epitope Diagnostics, Inc.