DEVICE: AESKULISA® Cenp-B (04250289500548)

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Device Identifier (DI) Information

AESKULISA® Cenp-B
3112

Aesku.Diagnostics GmbH & Co. KG
04250289500548
GS1
1
AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombinant human 80 kDa centromere protein B (Cenp-B) for the quantitative and qualitative detection of IgG antibodies against Cenp-B in human serum. The assay ensures the highest specificity and sensitivity for the detection of antibodies against centromere protein B, which serves as an aid in the diagnosis of systemic sclerosis and CREST syndrome.
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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
Centromere protein antibody (anti-CENP) 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 centromere protein (anti-CENP) in a clinical specimen, using an enzyme immunoassay (EIA) method.
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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

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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