DEVICE: AESKULISA tTg-A New Generation (04250289502870)

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Device Record History
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Device Identifier (DI) Information
AESKULISA tTg-A New Generation
30-7503US
In Commercial Distribution
30-7503US
Aesku.Diagnostics GmbH & Co. KG
04250289502870
GS1

1
341714388 *Terms of Use
The AESKULISA tTg-A New generation is a solid phase enzyme immunoassay for the quantitative and qualitative detection of IgA antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum. 30'+30'+30' automation incubation.
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Device Characteristics
Labeling does not contain MRI Safety Information
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No
Yes
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
55223 Tissue transglutaminase 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 tissue transglutaminase (anti-tTG) 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
MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K042644 000
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Sterilization
No
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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 Record Status
fc409511-3615-4fa6-ac05-ad6f92e6da76
July 06, 2018
3
February 21, 2017
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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
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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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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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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