DEVICE: Anti-RSV IFA (IgM) (04049016059264)

Device Identifier (DI) Information

Anti-RSV IFA (IgM)
FI 2670-1003 M
Not in Commercial Distribution

EUROIMMUN Medizinische Labordiagnostika AG
04049016059264
GS1
September 11, 2018
1
322209263 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
Yes
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
Respiratory syncytial virus (RSV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to respiratory syncytial virus (RSV) in a clinical specimen, using a fluorescent immunoassay method.
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FDA Product Code

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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

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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 Record Status

5cab64fc-99e9-48b5-ba5f-bc711b053e5b
September 14, 2018
3
September 24, 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)

[?]
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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