DEVICE: Anti-Parainfluenza Viruses Pool ELISA (IgA) (04049016028369)
Device Identifier (DI) Information
Anti-Parainfluenza Viruses Pool ELISA (IgA)
EI 2721-9601-1 A
In Commercial Distribution
EUROIMMUN Medizinische Labordiagnostika AG
EI 2721-9601-1 A
In Commercial Distribution
EUROIMMUN Medizinische Labordiagnostika AG
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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 human parainfluenza virus immunoglobulin A (IgA) 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 immunoglobulin A (IgA) antibodies to one or multiple strains of human parainfluenza virus in a clinical specimen, using an enzyme immunoassay (EIA) method. |
FDA Product Code
[?]Product Code | Product Code Name |
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GQT | Antisera, Cf, Parainfluenza Virus 1-4 |
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
e7ed9545-b3b1-4b97-81c9-78dcf912cbe2
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
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No Secondary DIs found |
Unit of Use DI
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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