DEVICE: AESKULISA® Jo-1 (04250289500555)

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Device Identifier (DI) Information

AESKULISA® Jo-1
3113

Aesku.Diagnostics GmbH & Co. KG
04250289500555
GS1
1
AESKULISA Jo-1 is a solid phase enzyme immunoassay with recombinant human histidyltRNA-synthetase (HRS) for the quantitative and qualitative detection of antibodies against Jo-1 (named after the prototype patient) in human serum. Human sera with anti-Jo-1 antibodies solely recognize HRS of higher eukaryotes and react with highest affinity with the human enzyme. The assay is a tool in the diagnosis of polymyositis and dermatomyositis.
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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 myositis-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 myositis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assayed antibodies may include autoimmune antibodies directed at Jo-1 (anti-Jo-1), ribonuclear protein (anti-RNP), Polymyositis-scleroderma (anti-PM-Scl), Ku (anti-Ku) and/or mitochondrial M2 (anti-Mi2).
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FDA Product Code

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Product Code Product Code Name
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
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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 27, 2016

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Alternative and Additional Identifiers Additional Identifiers

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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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