DEVICE: Light Diagnostics™ Simulfluor® HSV / VZV DFA (04053252371745)

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Device Identifier (DI) Information

Light Diagnostics™ Simulfluor® HSV / VZV DFA
3295
3295
EMD Millipore Corporation
04053252371745
GS1
1
Simulfluor HSV / VZV DFA Kit
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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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
Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a fluorescent immunoassay method.
Varicella-zoster virus (VZV) antigen IVD, kit, direct fluorescent test (DFT) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from varicella-zoster virus (VZV) in a clinical specimen, using a direct fluorescent test (DFT).
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FDA Product Code

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Product Code Product Code Name
GQW Antigen, Cf, (Including Cf Control), Varicella-Zoster
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Sterilization

No
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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 Status

In Commercial Distribution
September 09, 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
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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