Identity
- Trade Name
- Seraclone® Anti-k (KEL2) FDA UDI
- Generic Name
- Rhesus (Rh) phenotype (CcDEe)/Kell phenotype multiple blood grouping IVD, kit, agglutination FDA UDI
- Device Name
- Blood Grouping Reagent Anti-k (KEL2); Seraclone® Murine Monoclonal (Lk1); for tube test; 5ml FDA UDI
- Model / Reference
- 808125100 FDA UDI
- Description
- Blood Grouping Reagent Anti-k (KEL2); Seraclone® Murine Monoclonal (Lk1); for tube test; 5ml FDA UDI
Identifiers
- Catalog Number
- 808125100 FDA UDI
- Primary DI / UDI-DI
- 07611969951635 FDA UDI
- GMDN Term
- Rhesus (Rh) phenotype (CcDEe)/Kell phenotype multiple blood grouping IVD, kit, agglutination FDA UDI
Classification
- 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
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
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
Seraclone® Anti-k (KEL2) by Bio-Rad Medical Diagnostics GmbH — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Bio-Rad Medical Diagnostics GmbH
Sources (1)
- FDA UDI 515816c2-c92c-44b0-99e0-4dd159dde3a9 36 fields · synced May 29, 2026