Identity
- Trade Name
- Anti-D (Monoclonal Blend) Series 5 FDA UDI
- Generic Name
- Anti-Rh(D) red blood cell grouping IVD, antibody FDA UDI
- Device Name
- Anti-D Series 5 (Monoclonal Blend) is intended for use in slide, tube, microplate and automated tests, for the detection of the Rh (D) antigen. FDA UDI
- Model / Reference
- 0006414 FDA UDI
- Description
- Anti-D Series 5 (Monoclonal Blend) is intended for use in slide, tube, microplate and automated tests, for the detection of the Rh (D) antigen. FDA UDI
Identifiers
- Catalog Number
- 0006414 FDA UDI
- Primary DI / UDI-DI
- 10888234000563 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
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
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-Rh(D) red blood cell grouping IVD, antibody
Anti-D (Monoclonal Blend) Series 5 by Immucor, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anti-Rh(D) red blood cell grouping IVD, antibody.
- Beckman Coulter® PK® Systems Anti-D (PK1) (P3X61) — DIAGAST
- ORTHO — Ortho-Clinical Diagnostics
- Anti-D (RH1) IgM+IgG — DIAGAST
- Anti-D (RH1) IgM — DIAGAST
- IH-Anti D (RH1) Blend — Bio-Rad Medical Diagnostics GmbH
- IH-Card Anti-D (DVI-) — Bio-Rad Medical Diagnostics GmbH
- Beckman Coulter® PK® Systems Anti-D (PK2) (HM10) — DIAGAST
- Beckman Coulter® PK® Systems Anti-D (P3X61+P3X21223B10+P3X290+P3X35) — DIAGAST
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
- Immucor, Inc.
Sources (1)
- FDA UDI 74fde485-6de0-4b69-a58b-1a843c8a96ab 35 fields · synced May 31, 2026