Identity
- Trade Name
- Anti-S FDA UDI
- Generic Name
- Anti-S [MNS003] red blood cell grouping IVD, antibody FDA UDI
- Device Name
- Anti-S reagent is intended for the detection of the S (MNS3) antigen on red blood cells by tube test. FDA UDI
- Model / Reference
- 0007454 FDA UDI
- Description
- Anti-S reagent is intended for the detection of the S (MNS3) antigen on red blood cells by tube test. FDA UDI
Identifiers
- Catalog Number
- 0007454 FDA UDI
- Primary DI / UDI-DI
- 10888234000747 FDA UDI
- GMDN Term
- Anti-S [MNS003] 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-S [MNS003] red blood cell grouping IVD, antibody
Anti-S by Immucor, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anti-S [MNS003] red blood cell grouping IVD, antibody.
- Anti-S — AMERICAN NATIONAL RED CROSS
- ORTHOTM Sera Anti-S — ALBA BIOSCIENCE LIMITED
- ORTHO — Ortho-Clinical Diagnostics
- Seraclone® Anti-S (MNS3) — Bio-Rad Medical Diagnostics GmbH
- Anti-S (MNS3) — DIAGAST
- ALBAclone Anti-S (Monoclonal IgG) — ALBA BIOSCIENCE LIMITED
- Anti-S (Monoclonal) Gamma-clone — IMMUCOR, INC.
- Anti-S (Monoclonal) Gamma-clone — IMMUCOR, INC.
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
- Immucor, Inc.
Sources (1)
- FDA UDI de548e4b-545a-4dea-8356-2d72f017b19a 35 fields · synced Jun 1, 2026