← Back to catalogue

ORTHOTM Sera Anti-N Blood Grouping Reagent

FDA UDIEUDAMED

by Alba Bioscience Limited

Identity

Trade Name
ORTHOTM Sera Anti-N Blood Grouping Reagent FDA UDI
Generic Name
Anti-N red blood cell grouping IVD, antibody FDA UDI
Device Name
The Anti-N reagent (Anti-MNS2) is for the qualitative in vitro detection of human N positive red blood cells by the direct agglutination test. FDA UDI
Model / Reference
6904555 FDA UDI
Description
The Anti-N reagent (Anti-MNS2) is for the qualitative in vitro detection of human N positive red blood cells by the direct agglutination test. FDA UDI

Identifiers

Primary DI / UDI-DI
10758750013098 FDA UDI
GMDN Term
Anti-N 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

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-N red blood cell grouping IVD, antibody

ORTHOTM Sera Anti-N Blood Grouping Reagent by Alba Bioscience Limited — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Anti-N red blood cell grouping IVD, antibody.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Alba Bioscience Limited

Sources (2)

  • FDA UDI 94c4627b-9f9f-4137-a6c9-ffacef74f036 34 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026