Identity
- Trade Name
- Anti-D (Monoclonal Blend) Gamma-clone FDA UDI
- Generic Name
- Anti-Rh(D) red blood cell grouping IVD, antibody FDA UDI
- Device Name
- This reagent is used in slide, tube and microwell tests, for the detection of the Rh (D) antigen, of the Rhesus blood group system. The package configuration for this product code is three (3) vials of reagent. FDA UDI
- Model / Reference
- 0420503 FDA UDI
- Description
- This reagent is used in slide, tube and microwell tests, for the detection of the Rh (D) antigen, of the Rhesus blood group system. The package configuration for this product code is three (3) vials of reagent. FDA UDI
Identifiers
- Catalog Number
- 0420503 FDA UDI
- Primary DI / UDI-DI
- 10888234001768 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
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-Rh(D) red blood cell grouping IVD, antibody
Anti-D (Monoclonal Blend) Gamma-clone 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.
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- 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 0135a4fe-9498-4582-9531-c8a08a68f226 36 fields · synced Jun 8, 2026