Identity
- Trade Name
- Seraclone® Anti-B (ABO2) FDA UDI
- Generic Name
- Anti-B red blood cell grouping IVD, antibody FDA UDI
- Device Name
- Blood Grouping Reagent Anti-B (ABO2); Seraclone® Murine Monoclonal (B005); for tube test; 10x10ml FDA UDI
- Model / Reference
- 801350100 FDA UDI
- Description
- Blood Grouping Reagent Anti-B (ABO2); Seraclone® Murine Monoclonal (B005); for tube test; 10x10ml FDA UDI
Identifiers
- Catalog Number
- 801350100 FDA UDI
- Primary DI / UDI-DI
- 07611969950119 FDA UDI
- GMDN Term
- Anti-B red blood cell grouping IVD, antibody FDA UDI
Classification
- Commercial Distribution
- 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
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
Category: Anti-B red blood cell grouping IVD, antibody
Seraclone® Anti-B (ABO2) by Bio-Rad Medical Diagnostics GmbH — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anti-B red blood cell grouping IVD, antibody.
- Anti-B (Murine Monoclonal) Series 3 — IMMUCOR, INC.
- Anti-B (Murine Monoclonal) Gamma-clone — IMMUCOR, INC.
- Beckman Coulter® PK® Systems Anti-B (164B5G10+7821D9) — DIAGAST
- Beckman Coulter® PK® Systems Anti-B (9621A8) — DIAGAST
- Anti-B (Murine Monoclonal) Series 3 — IMMUCOR, INC.
- Anti-B (AB02) — DIAGAST
- BIOCLONE — Ortho-Clinical Diagnostics
- MTS — MICRO TYPING SYSTEMS, INC
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 b5e740bf-b0e0-451c-b7a7-07dd63537bdf 36 fields · synced May 30, 2026