DEVICE: GeneXpert Infinity-48s System (07332940004316)
Device Identifier (DI) Information
GeneXpert Infinity-48s System
INFINITY 48-48
In Commercial Distribution
900-0540
CEPHEID
INFINITY 48-48
In Commercial Distribution
900-0540
CEPHEID
Additional catalog numbers: 900-0540L, 900-0540R
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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No | |
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No |
GMDN
[?]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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OOI | Real Time Nucleic Acid Amplification System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -30 and 45 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6c9477c9-e61f-4c9b-bda8-56da61d18b21
May 11, 2018
3
September 12, 2016
May 11, 2018
3
September 12, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
18888383222
techsupport@cepheid.com
techsupport@cepheid.com