DEVICE: ELISA VZV IgG Q Test System (00845533001281)
Device Identifier (DI) Information
ELISA VZV IgG Q Test System
Q9Z9331GB
In Commercial Distribution
Q9Z9331GB
ZEUS SCIENTIFIC, INC.
Q9Z9331GB
In Commercial Distribution
Q9Z9331GB
ZEUS SCIENTIFIC, INC.
The ZEUS ELISA Varicella-Zoster Virus (VZV) IgG Test System is intended for the qualitative detection of VZV IgG antibody in human serum. When performed according to these instructions, the results of this test, together with other clinical information, may aid in the determination of immune status, and/or aid in the diagnosis of VZV infections. This test is intended for In Vitro diagnostic use.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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49621 | Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to varicella-zoster virus (VZV) in a clinical specimen, using an enzyme immunoassay (EIA) method.
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FDA Product Code
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FDA Premarket Submission
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
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Device Record Status
daa0131d-8021-434e-b264-1febe22dd4a9
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined