DEVICE: Anti-Glutamate receptor (type NMDA) IFA (04049016092544)

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Device Identifier (DI) Information

Anti-Glutamate receptor (type NMDA) IFA
FA 112d-1005-51

EUROIMMUN Medizinische Labordiagnostika AG
04049016092544
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
Yes
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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
N-methyl-D-aspartate (NMDA) receptor 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 antibodies to N-methyl-D-aspartate (NMDA) receptor (a glutamate receptor) in a clinical specimen, using a fluorescent immunoassay method. It is used to aid in the diagnosis of the autoimmune condition NMDA encephalitis, which causes neurologic and psychiatric symptoms.
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FDA Product Code

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Product Code Product Code Name
OSK Anti-Glutamate Receptor (Type Nmda) Ifa
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Sterilization

No
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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 Status

In Commercial Distribution
October 10, 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
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None
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Production Identifier(s) in UDI

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Yes
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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