Identity
- Trade Name
- Hema-Screen Lab Pack FDA UDI
- Generic Name
- Faecal occult blood IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- Hema-Screen is a guaiac slide test for the qualitative detection of fecal occult blood. FDA UDI
- Model / Reference
- 1290-100 FDA UDI
- Description
- Hema-Screen is a guaiac slide test for the qualitative detection of fecal occult blood. FDA UDI
Identifiers
- Catalog Number
- 1290-100 FDA UDI
- Primary DI / UDI-DI
- 00657498129012 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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-Screen Lab Pack by Stanbio Laboratory, L.p. — 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
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- 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
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 |
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Manufacturer
- Manufacturer
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI 375fcec4-3c19-4092-b806-226ebe39f16d 36 fields · synced May 30, 2026