Identity
- Trade Name
- Status iFOBTest Control Kit FDA UDI
- Generic Name
- Faecal occult blood IVD, control FDA UDI
- Device Name
- Status iFOBTest Control Kit (1 Pos/1 Neg) FDA UDI
- Model / Reference
- BSP-300-C-01 FDA UDI
- Description
- Status iFOBTest Control Kit (1 Pos/1 Neg) FDA UDI
Identifiers
- Catalog Number
- BSP-300-C-01 FDA UDI
- Primary DI / UDI-DI
- 10743816001102 FDA UDI
- GMDN Term
- Faecal occult blood IVD, control FDA UDI
Classification
- 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
Yes
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
Status iFOBTest Control Kit by Princeton Biomeditech Corp. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Princeton Biomeditech Corp.
Sources (1)
- FDA UDI 2435f71a-1469-4536-b792-ec2d2320acfd 36 fields · synced May 30, 2026