DEVICE: Reagent B - CMV Brite™ Turbo kit (00087179530223)

Device Identifier (DI) Information

Reagent B - CMV Brite™ Turbo kit
VIR-CMV110 RB BDC
In Commercial Distribution
VIR-CMV110 RB BDC
IQ Products B.V.
00087179530223
GS1

1
490578678 *Terms of Use
Reagent B is a component of the CMV Brite™ Turbo kit which can be used as a fixative peripheral blood leukocytes on slides. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Cytomegalovirus (CMV) antigen IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from cytomegalovirus (CMV) in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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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 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

835a1f1e-9153-48cf-b957-7a081d5eabe4
March 29, 2018
2
September 19, 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
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Customer Contact

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No Customer Contact currently defined
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