DEVICE: Xpert EV (07332940000097)

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Device Identifier (DI) Information

Xpert EV
GXEV-100N-10

CEPHEID
07332940000097
GS1
10
No description.
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multiple meningitis-associated microorganism nucleic acid IVD, kit, nucleic acid technique (NAT) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple microorgnamisms associated with meningitis, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include but are not limited to Streptococcus meningitidis, Neisseria meningitidis, Haemophilus influenzae, adenovirus, enterovirus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2). ), varicella-zoster virus (VZV), and Mumps virus.
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FDA Product Code

[?]
Product Code Product Code Name
OAI Assay, Enterovirus Nucleic Acid
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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 28 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 16, 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: 00000000061043 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1 888 838 3222
techsupport@cepheid.com
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