DEVICE: BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waved kit (00382902560456)
Device Identifier (DI) Information
BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waved kit
256045
In Commercial Distribution
256045
BECTON, DICKINSON AND COMPANY
256045
In Commercial Distribution
256045
BECTON, DICKINSON AND COMPANY
Kit Flu A+B 30 Test Physician Veritor
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
49119 | Influenza A/B virus antigen IVD, kit, rapid ICT, clinical |
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from influenza A virus and/or influenza B virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PSZ | Devices detecting influenza A, B, and C virus antigens |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K112277 | 000 |
K132259 | 000 |
K132692 | 000 |
K151291 | 000 |
K152870 | 000 |
K160161 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
bc754aff-f0a1-4a02-9f56-8f54f1b5d1af
May 15, 2025
5
February 02, 2017
May 15, 2025
5
February 02, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
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)638-8663
Technical_services@bd.com
Technical_services@bd.com