Identity
- Trade Name
- AFIAS-50 FDA UDI
- Generic Name
- Specimen processing instrument IVD FDA UDI
- Model / Reference
- FPRR022 FDA UDI
Identifiers
- Catalog Number
- FPRR022 FDA UDI
- Primary DI / UDI-DI
- 08806133010068 FDA UDI
- GMDN Term
- Specimen processing instrument IVD FDA UDI
Classification
- 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
Yes
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: Specimen processing instrument IVD
Afias-50 by Boditech Med, Inc. — 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
- Boditech Med, Inc.
Sources (1)
- FDA UDI a8578f5c-e7de-425f-85e9-9819b87ba232 34 fields · synced May 30, 2026