DEVICE: Influenza Virus A IgG ELISA (00404847437935)
Device Identifier (DI) Information
Influenza Virus A IgG ELISA
EIA-3793
Not in Commercial Distribution
EIA-3793
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3793
Not in Commercial Distribution
EIA-3793
DRG Instruments Gesellschaft mit beschränkter Haftung
The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]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? |
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49178 | Influenza A virus immunoglobulin G (IgG) 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 G (IgG) antibodies to influenza A virus in a clinical specimen, using an enzyme immunoassay (EIA) method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GNW | ANTISERA, CF, INFLUENZA VIRUS A, B, C |
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
c8b65e10-ea3d-4064-b68f-42497cc7be5f
November 21, 2024
2
June 07, 2021
November 21, 2024
2
June 07, 2021
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
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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
[?]
+1(973)564-7555
corp@drg-international.com
corp@drg-international.com