Identity
- Trade Name
- FOBT-CHEK FDA UDI
- Generic Name
- Faecal occult blood IVD, control FDA UDI
- Device Name
- Positive/Negative Controls for OC-Light and OC-Light S FDA UDI
- Model / Reference
- FBT-POC FDA UDI
- Description
- Positive/Negative Controls for OC-Light and OC-Light S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816917021539 FDA UDI
- FDA Product Code
- KHE FDA UDI
- GMDN Term
- Faecal occult blood IVD, control 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, control
Fobt-Chek by Polymedco Cancer Diagnostic Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Faecal occult blood IVD, control.
- InSure FIT — ENTERIX INC. · Class II
- HEMOSURE® — HEMOSURE INC.
- QuickVue — Quidel Corp. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Status iFOBTest Control Kit — PRINCETON BIOMEDITECH CORP.
- HEMOSURE® — HEMOSURE INC.
- InSure® ONE™ — ENTERIX INC. · Class II
- IFOB CONTROLS — GERMAINE LABORATORIES, INC. · Class II
Cleared under the same submission
K041297 also covers:
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.
- 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
- 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 25549813-60c4-4295-b496-62da4ddeec83 35 fields · synced Jun 6, 2026