DEVICE: IMAGEN RESPIRATORY SCREEN POS CON SLIDE (05032384503070)
Device Identifier (DI) Information
IMAGEN RESPIRATORY SCREEN POS CON SLIDE
S612130-2
In Commercial Distribution
OXOID LIMITED
S612130-2
In Commercial Distribution
OXOID LIMITED
No description.
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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48247 | Multiple-genus respiratory virus antigen IVD, control |
A material which is used to verify the performance of an assay 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. 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 |
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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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K973954 | 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
f6c1f3ce-2f1b-476d-b0a8-c0bb4887d7b9
July 11, 2024
1
July 03, 2024
July 11, 2024
1
July 03, 2024
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