DEVICE: Anti-BP180-NC16A-4X ELISA (IgG) (04049016026839)

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Device Identifier (DI) Information

Anti-BP180-NC16A-4X ELISA (IgG)
EA 1502-4801-2 G

EUROIMMUN Medizinische Labordiagnostika AG
04049016026839
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
Bullous pemphigoid antigen 2 (BPAG2) 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 bullous pemphigoid antigen 2 (BPAG2), also known as BP180, in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis of the autoimmune skin disease bullous pemphigoid.
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FDA Product Code

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Product Code Product Code Name
OEG Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
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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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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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