Identity
- Trade Name
- OC-Light S FDA UDI
- Generic Name
- Faecal occult blood IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Personal Use Kit OC-Light S, Custom Kit for Assured Imaging FDA UDI
- Model / Reference
- FBPUS-AI FDA UDI
- Description
- Personal Use Kit OC-Light S, Custom Kit for Assured Imaging FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816917023656 FDA UDI
- 510(k) Number
- K143325 FDA UDI
- FDA Product Code
- KHE FDA UDI
- GMDN Term
- Faecal occult blood IVD, kit, rapid ICT, 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 ICT, clinical
OC-Light S by Polymedco Cancer Diagnostic Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Faecal occult blood IVD, kit, rapid ICT, clinical.
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Cleared under the same submission
K143325 also covers:
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- FOBT-CHEK — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
- OC-Light S — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
- OC-Light S — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
- OC-Light S — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
- OC-Light S — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
- OC-Light S — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
- OC-Light S — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
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
- Polymedco Cancer Diagnostic Products Llc
Sources (1)
- FDA UDI 65277e1f-455c-406f-a5d0-2849ff8c1b50 35 fields · synced Jun 8, 2026