DEVICE: Xpert C. difficile (07332940000035)

Device Identifier (DI) Information

Xpert C. difficile
GXCDIFFICILE-10
In Commercial Distribution
GXCDIFFICILE-10
CEPHEID
07332940000035
GS1

1
956711444 *Terms of Use
Xpert C. difficile 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

[?]

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

GMDN Preferred Term Name GMDN Definition
Clostridium difficile 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, including specific gene markers from Clostridium difficile bacteria in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Markers detected may include genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027) and genes encoding toxin A and/or B.
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FDA Product Code

[?]
Product Code Product Code Name
LLH Reagents, Clostridium Difficile Toxin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K091109 000
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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 Record Status

b2db5f12-a3c6-4494-a894-19b85acb00a6
July 06, 2018
3
January 29, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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

[?]
1888 838 3222
techsupport@cepheid.com
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