DEVICE: QuantiFERON-TB Gold Reference Lab Pack (04053228002116)

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Device Identifier (DI) Information

QuantiFERON-TB Gold Reference Lab Pack
1
5940501
QIAGEN SCIENCES INC.
04053228002116
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
T-cell activation/stimulated interferon release IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of reactive T-cells in a clinical specimen which have become activated in response to stimulation by one or multiple specific antigens or mitogens, including (but not limited to) Borrelia species, Epstein-Barr virus (EBV), Cytomegalovirus (CMV), BK virus and/or Mycobacterium species. T-cell activation is detected through the release of interferon gamma (IFN gamma), using an enzyme immunoassay (EIA) method.
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FDA Product Code

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Product Code Product Code Name
NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
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Sterilization

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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 Status

In Commercial Distribution
January 04, 2017

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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
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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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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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