DEVICE: AESKUSLIDES® ANA-HEp-2 gamma (04250289513487)

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Device Identifier (DI) Information
AESKUSLIDES® ANA-HEp-2 gamma
51.181.US
In Commercial Distribution
51.181.US
Aesku.Diagnostics GmbH & Co. KG
04250289513487
GS1

1
341714388 *Terms of Use
AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum.
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Device Characteristics
Labeling does not contain MRI Safety Information
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No
Yes
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No
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No

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?
54808 Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen, using a fluorescent immunoassay method.
Active false
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FDA Product Code

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Product Code Product Code Name
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: 2-8°C
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
93246fcd-bd42-4269-8039-87ebba279476
April 14, 2025
1
April 06, 2025
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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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