Identity
- Trade Name
- Beckman Coulter® PK® Systems Anti-D (PK1) (P3X61) FDA UDI
- Generic Name
- Anti-Rh(D) red blood cell grouping IVD, antibody FDA UDI
- Device Name
- Blood Grouping Reagent Anti-D (Monoclonal-IgM) formulated for Automated Systems, Beckman Coulter® PK® Systems FDA UDI
- Model / Reference
- 17305 FDA UDI
- Description
- Blood Grouping Reagent Anti-D (Monoclonal-IgM) formulated for Automated Systems, Beckman Coulter® PK® Systems FDA UDI
Identifiers
- Catalog Number
- 17305 FDA UDI
- Primary DI / UDI-DI
- 23661562173055 FDA UDI
- GMDN Term
- Anti-Rh(D) 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
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
Category: Anti-Rh(D) red blood cell grouping IVD, antibody
Beckman Coulter® PK® Systems Anti-D (PK1) (P3X61) by Diagast — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anti-Rh(D) red blood cell grouping IVD, antibody.
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- IH-Anti D (RH1) Blend — Bio-Rad Medical Diagnostics GmbH
- IH-Card Anti-D (DVI-) — Bio-Rad Medical Diagnostics GmbH
- ALBAclone Anti-D blend — ALBA BIOSCIENCE LIMITED
- Anti-D (Monoclonal Blend) Gamma-clone — IMMUCOR, INC.
- Seraclone® Anti-D (RH1) Blend — 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
- Diagast
Sources (1)
- FDA UDI 1b789853-ec57-4c56-9d0d-6e2e3cbedc91 35 fields · synced Jun 6, 2026