DEVICE: Influenza A & B Virus Antigen Control Slide, 4 wells (B110QAB15040)

Device Identifier (DI) Information

Influenza A & B Virus Antigen Control Slide, 4 wells
QAB-1504
In Commercial Distribution
QAB-1504
Bion Enterprises, Ltd.
B110QAB15040
HIBCC

1
024824641 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
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?
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

[?]
Product Code Product Code Name
LJG Quality Control Slides
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K890616 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: less than 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

691afffc-1216-4db8-94cb-5c915c3ae8af
March 04, 2020
4
September 12, 2016
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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
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
847-544-5044
bion@mblintl.com
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