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IFA: Granulocyte Mosaic 13

FDA UDI

Class II (US FDA UDI)

by EUROIMMUN Medizinische Labordiagnostika AG

Identity

Trade Name
IFA: Granulocyte Mosaic 13 FDA UDI
Generic Name
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent FDA UDI
Model / Reference
FB 1201-2010-13 FDA UDI

Identifiers

Primary DI / UDI-DI
04049016072102 FDA UDI
510(k) Number
K051489 FDA UDI
FDA Product Code
MOB FDA UDI
GMDN Term
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

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: Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent

IFA: Granulocyte Mosaic 13 by EUROIMMUN Medizinische Labordiagnostika AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent.

Cleared under the same submission

K051489 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
EUROIMMUN Medizinische Labordiagnostika AG

Sources (1)

  • FDA UDI e91d7dab-7abc-43b2-a89c-cf9cb2bb367d 34 fields · synced Jun 8, 2026