Identity
- Trade Name
- Beckman Coulter® PK® Systems Anti-e (P3GD512+MS63) FDA UDI
- Generic Name
- Anti-E [RH005] red blood cell grouping IVD, antibody FDA UDI
- Device Name
- Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® 7300 Systems FDA UDI
- Model / Reference
- 17319 FDA UDI
- Description
- Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® 7300 Systems FDA UDI
Identifiers
- Catalog Number
- 17319 FDA UDI
- Primary DI / UDI-DI
- 23661562173192 FDA UDI
- GMDN Term
- Anti-E [RH005] red blood cell grouping IVD, antibody FDA UDI
Classification
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
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
Beckman Coulter® PK® Systems Anti-e (P3GD512+MS63) by Diagast — 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
- Diagast
Sources (1)
- FDA UDI c1746b6b-99cb-4d7d-978a-e748852c757e 36 fields · synced Jun 1, 2026