Identity
- Trade Name
- TRI-SLIDE PATIENT ENVELOPE KIT FDA UDI
- Generic Name
- Faecal occult blood IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- Cenogenics Corporation's TRI-SLIDE PATIENT ENVELOPE KIT is a six test guaiac slide procedure to effectively screen for intermittent gastrointestinal bleeding. The Kit Contains: 50 patient envelope kits. Each Patient Kit contains one Tri-Slide with controls and 3 applicator sticks. The envelopes are printed with easy to understand patient instructions. 3 X 10ml developing solution Product Instructions FDA UDI
- Model / Reference
- SB-19 FDA UDI
- Description
- Cenogenics Corporation's TRI-SLIDE PATIENT ENVELOPE KIT is a six test guaiac slide procedure to effectively screen for intermittent gastrointestinal bleeding. The Kit Contains: 50 patient envelope kits. Each Patient Kit contains one Tri-Slide with controls and 3 applicator sticks. The envelopes are printed with easy to understand patient instructions. 3 X 10ml developing solution Product Instructions FDA UDI
Identifiers
- Catalog Number
- SB-19 FDA UDI
- Primary DI / UDI-DI
- B224SB191 FDA UDI
- 510(k) Number
- K761232 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
Tri-Slide Patient Envelope Kit by Cenogenics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K761232 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 |
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Manufacturer
- Manufacturer
- Cenogenics Corp.
Sources (1)
- FDA UDI 5fa17a9e-6b49-4f7f-ad10-5f3088f87e23 35 fields · synced Jun 8, 2026