Identity
- Trade Name
- ForSure iFOB Test (cassette only) FDA UDI
- Generic Name
- Faecal occult blood IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- ForSure iFOB test cassette only (no buffer) FDA UDI
- Model / Reference
- 10210 FDA UDI
- Description
- ForSure iFOB test cassette only (no buffer) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00748349000076 FDA UDI
- 510(k) Number
- K063693 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
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 ICT, clinical
ForSure iFOB Test (cassette only) by Syntron Bioresearch, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Faecal occult blood IVD, kit, rapid ICT, clinical.
- Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- OC-Light S — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC · Class II
- HEMOSURE® — HEMOSURE INC. · Class II
- QuickVue — Quidel Corp. · Class II
- Status iFOBTest — PRINCETON BIOMEDITECH CORP. · Class II
- Hemoccult — Beckman Coulter, Inc. · Class II
- QMedix™ — Diagnostic Automation, Inc. · Class II
- MD DrugScreen — MEDICAL DISPOSABLES CORP · Class II
Cleared under the same submission
K063693 also covers:
- Accutest iFOB Positive and Negative Hemoglobin Controls — JANT PHARMACAL CORP.
- Accutest iFOBT - Dual Sample Fecal Occult Blood Test — JANT PHARMACAL CORP.
- Accutest iFOBT - Dual Sample Specimen Collection Kits — JANT PHARMACAL CORP.
- Accutest iFOBT - Single Sample Immunological Fecal Occult Blood Test — JANT PHARMACAL CORP.
- Accutest iFOBT - Specimen Collection Kit — JANT PHARMACAL CORP.
- Accutest iFOBT - Specimen Collection Tubes — JANT PHARMACAL CORP.
- ForSure iFOB Test (buffer only) — SYNTRON BIORESEARCH, INC.
- ForSure iFOB Test Set — SYNTRON BIORESEARCH, INC.
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
- Syntron Bioresearch, Inc.
Sources (1)
- FDA UDI cc6eebdc-6ba8-49c8-b5f4-28857712b00c 34 fields · synced May 31, 2026