Identity
- Trade Name
- Anti-e (RH5) FDA UDI
- Generic Name
- Anti-E [RH005] red blood cell grouping IVD, antibody FDA UDI
- Device Name
- Blood Grouping Reagent, Anti-e (Human/Murine Monoclonal) (P3GD512+MS63) - This reagent is designed to determine the presence of the blood group antigen e (Rh5) on the surface of human red blood cells by manual tube method. FDA UDI
- Model / Reference
- 210530 FDA UDI
- Description
- Blood Grouping Reagent, Anti-e (Human/Murine Monoclonal) (P3GD512+MS63) - This reagent is designed to determine the presence of the blood group antigen e (Rh5) on the surface of human red blood cells by manual tube method. FDA UDI
Identifiers
- Catalog Number
- 210230 FDA UDI
- Primary DI / UDI-DI
- 23661562105308 FDA UDI
- GMDN Term
- Anti-E [RH005] red blood cell grouping IVD, antibody FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anti-E [RH005] red blood cell grouping IVD, antibody
Anti-e (RH5) by Diagast — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anti-E [RH005] red blood cell grouping IVD, antibody.
- ALBAclone® Anti-e — ALBA BIOSCIENCE LIMITED
- BIOCLONE — Ortho-Clinical Diagnostics
- IH-Card Anti-e — Bio-Rad Medical Diagnostics GmbH
- MTS — MICRO TYPING SYSTEMS, INC
- IH-Card Anti-e — Bio-Rad Medical Diagnostics GmbH
- Anti-e (Monoclonal Blend) Gamma-clone — IMMUCOR, INC.
- Seraclone® Anti-e (RH5) — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagast
Sources (1)
- FDA UDI 7323814f-2430-40b5-bbb5-bf6b4b63ca52 35 fields · synced Jun 8, 2026