DEVICE: Xpert Carba-R (07332940001032)

Device Identifier (DI) Information

Xpert Carba-R
GXCARBAR-10
In Commercial Distribution
GXCARBAR-10
CEPHEID
07332940001032
GS1

1
956711444 *Terms of Use
Xpert Carba-R test; 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 bacteria carbapenemase 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 carbapenemase genes conferring carbapenem resistance in multiple types of bacteria present in a clinical specimen, using a nucleic acid technique (NAT), which may include (but not limited to) KPC, NDM, VIM, and OXA. Additional genes (e.g., vanA and vanB) conferring resistance to specific antimicrobial drugs (e.g., vancomycin) may also be detected.
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FDA Product Code

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Product Code Product Code Name
POC System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
PMY System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K173263 000
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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

210dc75b-dd1b-4a7d-961d-85d8afa14cdf
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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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