DEVICE: Light Diagnostics™ Rabies DFA Reagent (04053252739408)

Device Identifier (DI) Information

Light Diagnostics™ Rabies DFA Reagent
5100
In Commercial Distribution
5100
EMD Millipore Corporation
04053252739408
GS1

1
829517072 *Terms of Use
Rabies DFA Reagent
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

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
Rabies virus antigen IVD, antibody One or multiple immunoglobulins with the capability of binding to specific antigenic determinants intended to be used for the qualitative and/or quantitative detection of antigens from Rabies virus in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
GOI Antiserum, Fluorescent, Rabies Virus
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

94f7e3b3-c62b-442d-9cf7-811fd2bcf634
March 29, 2018
2
September 23, 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
No CLOSE

Customer Contact

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No Customer Contact currently defined
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