DEVICE: Alere Influenza A & B Control Swab Kit (10811877010880)

Device Identifier (DI) Information

Alere Influenza A & B Control Swab Kit
412-080
Not in Commercial Distribution

Alere Scarborough, Inc.
10811877010880
GS1
January 28, 2021
1
154148498 *Terms of Use
The Control Swabs are intended for use only with the Alere Influenza A & B Test.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
Yes
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Yes
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No

GMDN

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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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
PSZ Devices Detecting Influenza A, B, And C Virus Antigens
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

b33f1d39-57d8-40bd-8ed6-b6ebb0ad958c
September 12, 2023
3
January 01, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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