DEVICE: AESKULISA® Scl-70 (04250289500531)

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Device Identifier (DI) Information

AESKULISA® Scl-70
3111

Aesku.Diagnostics GmbH & Co. KG
04250289500531
GS1
1
AESKULISA Scl-70 is a solid phase enzyme immunoassay with human recombinant 70 kDa fragment of DNA topoisomerase I for the quantitative and qualitative detection of antibodies against Scl-70 (70 kDa scleroderma antigen) in human serum. The assay is a tool in the differential diagnosis of systemic sclerosis.
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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
Scleroderma-70 antibody (anti-Scl-70) 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 scleroderma-70 (anti-Scl-70) 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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None
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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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