DEVICE: Acucy Influenza A&B Control Kit (00742860100383)
Device Identifier (DI) Information
Acucy Influenza A&B Control Kit
1011
In Commercial Distribution
SEKISUI DIAGNOSTICS, LLC
1011
In Commercial Distribution
SEKISUI DIAGNOSTICS, LLC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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? |
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49121 | Influenza A/B 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 influenza A virus and/or influenza B virus in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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PSZ | Devices Detecting Influenza A, B, And C Virus Antigens |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
8bb4bed0-e691-44b7-9c8a-bf7a5b55189f
September 02, 2019
1
August 23, 2019
September 02, 2019
1
August 23, 2019
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:
10742860100380
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined