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EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)

FDA UDI

Class II (US FDA UDI)

by EUROIMMUN Medizinische Labordiagnostika AG

Identity

Trade Name
EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) FDA UDI
Generic Name
Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
DL 1300-6401-8 G FDA UDI

Identifiers

Primary DI / UDI-DI
04049016124894 FDA UDI
510(k) Number
K113439 FDA UDI
FDA Product Code
NUM FDA UDI
NRI FDA UDI
NIY FDA UDI
NBS FDA UDI
DBM FDA UDI
GMDN Term
Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5090 FDA UDI
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 liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) by EUROIMMUN Medizinische Labordiagnostika AG — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K113439 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 a4e9551c-ffee-42b1-a8a8-a84f92338ece 34 fields · synced May 30, 2026