DEVICE: EUROLINE ENA ProfilePlus 4 (IgG) (04049016084785)
Device Identifier (DI) Information
EUROLINE ENA ProfilePlus 4 (IgG)
DL 1590-6401-4 G
In Commercial Distribution
EUROIMMUN Medizinische Labordiagnostika AG
DL 1590-6401-4 G
In Commercial Distribution
EUROIMMUN Medizinische Labordiagnostika AG
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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Yes | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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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. |
FDA Product Code
[?]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 |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1de2595b-5e36-4307-87cc-7c90cce6c812
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined