Identity
- Trade Name
- Hema-Chek® Developer FDA UDI
- Generic Name
- Faecal occult blood IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- For use with the in vitro diagnostic Hema-Chek® Slide Test for the Qualitatitive Determination of Fecal Occult Blood. FDA UDI
- Model / Reference
- 10313614 FDA UDI
- Description
- For use with the in vitro diagnostic Hema-Chek® Slide Test for the Qualitatitive Determination of Fecal Occult Blood. FDA UDI
Identifiers
- Catalog Number
- 2596 FDA UDI
- Primary DI / UDI-DI
- 00630414538396 FDA UDI
- 510(k) Number
- K830223 FDA UDI
- FDA Product Code
- KHE FDA UDI
- GMDN Term
- Faecal occult blood IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.6550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Faecal occult blood IVD, kit, rapid colorimetric, clinical
Hema-Chek® Developer by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Faecal occult blood IVD, kit, rapid colorimetric, clinical.
- ColoScreen — Helena Laboratories, Corp. · Class II
- Hemoccult — Beckman Coulter, Inc. · Class II
- hema-screen ER — IMMUNOSTICS, INC. · Class II
- PremierPro — SVS LLC · Class II
- ColoScreen iFOBT Cassettes — Helena Laboratories, Corp. · Class II
- Fisher FOBT Tape — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- ColoScreen iFOBT Mailer — Helena Laboratories, Corp. · Class II
Cleared under the same submission
K830223 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI b425a465-71fa-479f-adf0-e6e1abd50a8a 37 fields · synced May 31, 2026