DEVICE: PathoDX Respiratory Viral Panel (05056080501680)
Device Identifier (DI) Information
PathoDX Respiratory Viral Panel
R62400
In Commercial Distribution
REMEL EUROPE LIMITED
R62400
In Commercial Distribution
REMEL EUROPE LIMITED
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
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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? |
---|---|---|---|---|
48243 | Multiple-genus respiratory virus 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 multiple virus genera associated with respiratory diseases in a clinical specimen, using a fluorescent immunoassay method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K983336 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a96cdbbe-18bb-4468-b966-b0defc7c32bd
December 18, 2023
2
July 21, 2021
December 18, 2023
2
July 21, 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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4401256694238
microbiology.techsupport.uk@thermofisher.com
microbiology.techsupport.uk@thermofisher.com