DEVICE: Anti-PLA2R ELISA (IgG) (04049016102748)

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Device Identifier (DI) Information

Anti-PLA2R ELISA (IgG)
EA 1254-9601 G

EUROIMMUN Medizinische Labordiagnostika AG
04049016102748
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
Phospholipase A2 receptor (PLA2R) antibody IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to the phospholipase A2 receptor (PLA2R) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis of the kidney disease known as primary membranous glomerulonephritis.
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FDA Product Code

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Product Code Product Code Name
PGV Anti-Phospholipase A2 Receptor
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Sterilization

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Sterilization Method [?]
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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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Size Type Text
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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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Secondary DI

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Unit of Use DI

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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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