PA500 Portrait Analyzer

Basic Information

• Brand Name: PA500 Portrait Analyzer
• Primary DI: B178PA5000
• Version / Model: PA500
• Catalog Number: PA500
• Company Name: GREAT BASIN SCIENTIFIC, INC.
• Labeler DUNS: 827115259
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2025-07-14
• Public Version Status: Update
• Public Device Record Key: 125bde7d-9182-45a1-af9e-f054a3fa4403

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	862.2570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48029	Isothermal nucleic acid amplification analyser IVD, laboratory, automated	An electrically-powered laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen at a constant (isothermal) temperature, using a series of transcription and reverse transcription reactions, and to detect and/or identify the amplified product using oligonucleotide markers as it is produced (i.e., in real-time). The device operates with minimal technician involvement and complete automation of all procedural steps.	No	Obsolete
48031	Thermal cycler nucleic acid amplification analyser IVD, laboratory	An electrically-powered automated or semi-automated 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 quantified 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B178PA5000	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 16 – 30 Degrees Celsius