DEVICE: Respiratory Virus Panel Antigen Control Slide, 14 wells (B110QRP63140)

Device Identifier (DI) Information

Respiratory Virus Panel Antigen Control Slide, 14 wells
QRP-6314
In Commercial Distribution
QRP-6314
MBL Bion
B110QRP63140
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multiple respiratory 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 one or multiple antigens from viruses associated with respiratory diseases in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.
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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
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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

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Size Type Text
No Device Sizes
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Device Record Status

190edcd3-aea8-455e-b14d-0273c6e9687b
July 06, 2018
3
September 12, 2016
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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)

[?]
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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