DEVICE: Light Diagnostics ™ RSV Monoclonal Antibody (04053252589591)

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Device Record History
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Device Identifier (DI) Information
Light Diagnostics ™ RSV Monoclonal Antibody
5006
Not in Commercial Distribution
5006
EMD Millipore Corporation
04053252589591
GS1
April 30, 2023
1
829517072 *Terms of Use
RSV Monoclonal Antibody
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
No
No
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?
48243 Multiple-genus respiratory virus 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 multiple virus genera associated with respiratory diseases in a clinical specimen, using a fluorescent immunoassay method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
39bafdc8-2fcc-410e-a460-82bf9dd38691
December 18, 2023
3
November 29, 2022
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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

[?]
1 (951) 676-8080
R128863@merckgroup.com
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