DEVICE: Light Diagnostics ™ Coxsackievirus A Control Slides (04053252404290)
Device Identifier (DI) Information
Light Diagnostics ™ Coxsackievirus A Control Slides
5076
Not in Commercial Distribution
5076
EMD Millipore Corporation
5076
Not in Commercial Distribution
5076
EMD Millipore Corporation
Coxsackievirus A Control Slides
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
48561 | Coxsackie A/B virus 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 multiple Coxsackie virus antigens from group A and B in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GNM | Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K940471 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
5ee8c9c0-3a59-4f72-a876-76d4152bb5b0
August 25, 2023
2
November 30, 2022
August 25, 2023
2
November 30, 2022
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1 (951) 676-8080
R128863@merckgroup.com
R128863@merckgroup.com