DEVICE: ImmunoCard STAT! FLU A&B Nasopharyngeal Wash/Aspriate Kit (00840733101649)

Device Identifier (DI) Information

ImmunoCard STAT! FLU A&B Nasopharyngeal Wash/Aspriate Kit
781130
In Commercial Distribution
781130
MERIDIAN BIOSCIENCE, INC.
00840733101649
GS1

1
092815364 *Terms of Use
Nasopharyngeal Wash/Aspirate Kit for use with ImmunoCard STAT! FLU A&B. ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Moderate Complexity when used with Nasal Wash/Aspirate Samples.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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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?
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.
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 [?]
K083746 000
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

c17b1804-d3f5-4c0d-a5f5-130dddeee41e
June 10, 2022
3
March 12, 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
No
Yes
No
No CLOSE

Customer Contact

[?]
(513) 271-3700
info@meridianbioscience.com
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