Identity
- Trade Name
- HLA-B SSP Kit FDA UDI
- Generic Name
- HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- for 24 determinations of HLA-B alleles; For In Vitro Diagnostic Use FDA UDI
- Model / Reference
- 826206 FDA UDI
- Description
- for 24 determinations of HLA-B alleles; For In Vitro Diagnostic Use FDA UDI
Identifiers
- Catalog Number
- 826206 FDA UDI
- Primary DI / UDI-DI
- 07611969953264 FDA UDI
- FDA Product Code
- MZI FDA UDI
- GMDN Term
- HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
HLA-B SSP Kit by Bio-Rad Medical Diagnostics GmbH — Class U — 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 U | Pending data |
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Manufacturer
- Manufacturer
- Bio-Rad Medical Diagnostics GmbH
Sources (1)
- FDA UDI 928042a7-8467-4727-a7ca-3ae11423432f 37 fields · synced Jun 8, 2026