DEVICE: EUROLINE ENA Profile 9 Ag (IgG) (04049016124917)

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Device Identifier (DI) Information

EUROLINE ENA Profile 9 Ag (IgG)
DL 1590-6401-9 G

EUROIMMUN Medizinische Labordiagnostika AG
04049016124917
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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No

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 extractable nuclear antigen auto-antibody (anti-ENA) screening 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 auto-antibodies to extractable nuclear antigens (anti-ENA) 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
LLL Extractable Antinuclear Antibody, Antigen And Control
MQA Anti-Ribosomal P Antibodies
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
LKO Anti-Rnp Antibody, Antigen And Control
LKP Anti-Sm Antibody, Antigen And Control
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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 Status

In Commercial Distribution
September 24, 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
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
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None
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Production Identifier(s) in UDI

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Yes
No
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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