Identity
- Trade Name
- ichroma Reader FDA UDI
- Generic Name
- Faecal occult blood immunoassay analyser IVD, semi-automated FDA UDI
- Model / Reference
- FPRR001 FDA UDI
Identifiers
- Catalog Number
- FPRR001 FDA UDI
- Primary DI / UDI-DI
- 08806133032008 FDA UDI
- FDA Product Code
- OOX FDA UDI
- GMDN Term
- Faecal occult blood immunoassay analyser IVD, semi-automated 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Faecal occult blood immunoassay analyser IVD, semi-automated
ichroma Reader by Boditech Med, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Boditech Med, Inc.
Sources (1)
- FDA UDI 74b93905-e7cd-4f14-a240-c093d3915334 34 fields · synced May 31, 2026