DEVICE: EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) (04049016124887)

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Device Identifier (DI) Information

EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)
DL 1300-1601-8 G

EUROIMMUN Medizinische Labordiagnostika AG
04049016124887
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with liver disease in a clinical specimen, using an enzyme immunoassay (EIA) method. The assayed antibodies may include autoimmune antibodies directed at liver-kidney microsome 1 protein (anti-LKM1), smooth muscle (anti-SMA), F-Actin, soluble liver antigen (SLA), Sp-100 protein, glycoprotein-210 (gp210), lamin B receptor (LBR) and also liver cytosol specific antibody type 1 (anti-LC1) and/or antimitochondrial antibodies (AMA).
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FDA Product Code

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Product Code Product Code Name
NUM Autoantibodies, Nuclear Body Protein, Sp100
NRI Autoantibodies, Nuclear Pore Glycoprotein Gp210
NIY Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
NBS Autoantibodies,Lkm-1(Liver/Kidney Microsome,Type 1)
DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 24, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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