Identity
- Trade Name
- B.R.A.H.M.S Basiskit LIA FDA UDI
- Generic Name
- Chemiluminescent immunoassay signal generation kit IVD FDA UDI
- Model / Reference
- 371.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260157633711 FDA UDI
- FDA Product Code
- NTM FDA UDI
- GMDN Term
- Chemiluminescent immunoassay signal generation kit IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3210 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
B.R.A.H.M.S Basiskit LIA by B.R.A.H.M.S GmbH — 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
- B.R.A.H.M.S GmbH
Sources (1)
- FDA UDI dc8af346-7ff0-4239-8c6c-7022ee5a99e9 33 fields · synced Jun 8, 2026