GeneSTAT

Primary DI
A91004001
Brand
GeneSTAT
Company
DXNA LLC
Model
91004001
Device description
Automated PCR analyzer
Published
2018-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QAACoccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QAACoccidioides Spp. Nucleic Acid Detection System For Respiratory SpecimensMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
A91004001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratory, automatedA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4356280324techsupport@dxna.com

Regulatory Flags#

DUNS number
789485377
Device count
1
Kit
true
Serial number
true