DEVICE: Certified Pre-Owned GeneXpert Dx System (07332940003890)

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Device Identifier (DI) Information

Certified Pre-Owned GeneXpert Dx System
GXIV-4-R
900-0513R
CEPHEID
07332940003890
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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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
Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated A mains electricity (AC-powered) laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification, and operates with minimal technician input and complete automation of all procedural steps.
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FDA Product Code

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Product Code Product Code Name
OOI Real Time Nucleic Acid Amplification System
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Sterilization

No
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -30 and 45 Degrees Celsius
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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
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: 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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No
Yes
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No CLOSE

Customer Contact

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18888383222
techsupport@cepheid.com
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