DEVICE: FLU/RSV Positive Control (00840733101977)
Device Identifier (DI) Information
FLU/RSV Positive Control
751110
Not in Commercial Distribution
751110
MERIDIAN BIOSCIENCE, INC.
751110
Not in Commercial Distribution
751110
MERIDIAN BIOSCIENCE, INC.
FLU/RSV Positive Control is an external control reagent to be used with TRU FLU and TRU RSV Test Kits as part of a routine quality control program
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
48264 | Influenza virus/respiratory syncytial virus (RSV) 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 influenza viruses (e.g., influenza A, influenza B) and respiratory syncytial virus (RSV) in a clinical specimen.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K071101 | 000 |
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
db9fefcd-9c8a-4a2d-9bc9-a746f737af0d
June 21, 2021
2
November 17, 2020
June 21, 2021
2
November 17, 2020
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
[?]
1-800-343-3858
MBI-TechService@meridianbioscience.com
MBI-TechService@meridianbioscience.com