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ELISA enzyme conjugate, anti-human IgA

FDA UDI

Class I (US FDA UDI)

by EUROIMMUN Medizinische Labordiagnostika AG

Identity

Trade Name
ELISA enzyme conjugate, anti-human IgA FDA UDI
Generic Name
Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD FDA UDI
Model / Reference
AE 121-1012 FDA UDI

Identifiers

Primary DI / UDI-DI
04049016151562 FDA UDI
FDA Product Code
PPM FDA UDI
GMDN Term
Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4010 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD

ELISA enzyme conjugate, anti-human IgA by EUROIMMUN Medizinische Labordiagnostika AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD.

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 0763a1fb-6f9a-4219-a396-fc796d76c0e5 32 fields · synced May 30, 2026