PA500 Portrait Analyzer PA500

GUDID B178PA5000

GREAT BASIN SCIENTIFIC, INC.

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

• Primary Device ID: B178PA5000
• NIH Device Record Key: 125bde7d-9182-45a1-af9e-f054a3fa4403
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PA500 Portrait Analyzer
• Version Model Number: PA500
• Catalog Number: PA500
• Company DUNS: 827115259
• Company Name: GREAT BASIN SCIENTIFIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com
• Phone: (888) 333-9763
• Email: customersupport@gbscience.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B178PA5000 [Primary]

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

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• B178SBPP102 - Stool Bacterial Pathogens Panel: 2018-03-29 Stool Bacterial Pathogens Panel Cartridge with sample prep device.
• B178GBSTEC102 - Shiga Toxin Direct Test: 2018-03-29 Shiga Toxin Direct Test Cartridge with sample prep device.
• B178PA5000 - PA500 Portrait Analyzer: 2018-03-29
• B178PA5000 - PA500 Portrait Analyzer: 2018-03-29