Identity
- Trade Name
- Seraclone® Anti-E (RH3) FDA UDI
- Generic Name
- Anti-E [RH003] red blood cell grouping IVD, antibody FDA UDI
- Device Name
- Blood Grouping Reagent Anti-E (RH3); Seraclone® Human Monoclonal (MS260/MS12); for tube test; 5ml FDA UDI
- Model / Reference
- 802336100 FDA UDI
- Description
- Blood Grouping Reagent Anti-E (RH3); Seraclone® Human Monoclonal (MS260/MS12); for tube test; 5ml FDA UDI
Identifiers
- Catalog Number
- 802336100 FDA UDI
- Primary DI / UDI-DI
- 07611969950430 FDA UDI
- GMDN Term
- Anti-E [RH003] 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-E [RH003] red blood cell grouping IVD, antibody
Seraclone® Anti-E (RH3) by Bio-Rad Medical Diagnostics GmbH — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Anti-E [RH003] red blood cell grouping IVD, antibody.
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- BIOCLONE — Ortho-Clinical Diagnostics
- MTS — MICRO TYPING SYSTEMS, INC
- Anti-E (RH3) — DIAGAST
- IH-Card Anti-E — Bio-Rad Medical Diagnostics GmbH
- IH-Card Anti-E — Bio-Rad Medical Diagnostics GmbH
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 870296c7-1f9c-4dbb-a16f-8bcc4ad318f5 36 fields · synced May 30, 2026