FDA.reportPublic FDA data

PA500 Portrait Analyzer

Primary DI
B178PA5000
Brand
PA500 Portrait Analyzer
Company
GREAT BASIN SCIENTIFIC, INC.
Model
PA500
Catalog number
PA500
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NSUInstrumentation For Clinical Multiplex Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B178PA5000PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature16 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(888) 333-9763customersupport@gbscience.com

Regulatory Flags#

DUNS number
827115259
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B178GBSBPP100Stool Bacterial Pathogens PanelGBSBPP-10GBSBPP-102017-07-24
B178GBSTEC100Shiga Toxin Direct TestGBSTEC-10GBSTEC-102016-09-23
B178GBSIDR100Staph ID/R Blood Culture PanelGBSIDR-10GBSIDR-102016-09-23
B178GBSIDR102Staph ID/R Blood Culture PanelGBSIDR-10GBSIDR-102016-09-23
B178GBBORD100Bordetella Direct TestGBBORD-10GBBORD-102017-07-12
B178GBCDIFF100Portrait Toxigenic C. difficile AssayGBCDIFF-10GBCDIFF-102016-09-23
B178GBGBS100Group B Strep AssayGBGBS-10GBGBS-102016-09-23
B178SBPP102Stool Bacterial Pathogens PanelGBSBPP-10GBSBPP-102017-07-24
B178GBSTEC102Shiga Toxin Direct TestGBSTEC-10GBSTEC-102016-09-23

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Primary DI, Brand, Company table
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05060441760005binx ioBINX HEALTH LIMITEDNSU2025-09-03
10190302019897Applied BioSystems™ ABY™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
10190302019903Applied BioSystems™ JUN™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
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