DEVICE: ARGENE® CINAkit HCMV ppUL83 US (03573026390273)
Device Identifier (DI) Information
ARGENE® CINAkit HCMV ppUL83 US
19-0028US
Not in Commercial Distribution
BIOMERIEUX SA
19-0028US
Not in Commercial Distribution
BIOMERIEUX SA
Argene CINAKit is intended for use as an aid in the diagnosis of Cytomegalovirus (CMV) infection by the qualitative detection of CMV pp65 antigen by indirect immunofluore scence
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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49707 | Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from cytomegalovirus (CMV) in a clinical specimen, using a fluorescent immunoassay method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K982311 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
8eeb3922-77fe-45d3-85de-a8f14e50d652
July 06, 2018
4
October 17, 2016
July 06, 2018
4
October 17, 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
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No Customer Contact currently defined