DEVICE: Xpert FLU/RSV XC (07332940000783)

Device Identifier (DI) Information

Xpert FLU/RSV XC
GXFLU/RSV-10
In Commercial Distribution
GXFLU/RSV-10
CEPHEID
07332940000783
GS1

1
956711444 *Terms of Use
Xpert FLU/RSV XC kit; 10 test kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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
Multiple respiratory virus 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 viruses associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.
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FDA Product Code

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Product Code Product Code Name
OCC Respiratory Virus Panel Nucleic Acid Assay System
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K142045 000
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
Storage Environment Temperature: between 2 and 28 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

03e6b4f0-26d8-4293-b21e-daab64dcd559
July 06, 2018
3
January 29, 2018
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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