Shiga Toxin Direct Test GBSTEC-10

GUDID B178GBSTEC102

Shiga Toxin Direct Test Cartridge with sample prep device.

GREAT BASIN SCIENTIFIC, INC.

Multiple gastrointestinal pathogen nucleic acid IVD, kit, microarray

• Primary Device ID: B178GBSTEC102
• NIH Device Record Key: 61b9df43-2304-496f-805c-5e01058e9d64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shiga Toxin Direct Test
• Version Model Number: GBSTEC-10
• Catalog Number: GBSTEC-10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B178GBSTEC100 [Primary]
HIBCC	B178GBSTEC102 [Package]; Contains: B178GBSTEC100; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• OOI: Real Time Nucleic Acid Amplification System

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

Devices Manufactured by GREAT BASIN SCIENTIFIC, INC.

• B178GBSIDR102 - Staph ID/R Blood Culture Panel: 2019-01-23
• B178GBBORD100 - Bordetella Direct Test: 2018-03-29 Bordetella Direct Test Cartridge
• B178GBCDIFF100 - Portrait Toxigenic C. difficile Assay: 2018-03-29 C. diff Assay Cartridge and Sample Prep Device.
• B178GBGBS100 - Group B Strep Assay: 2018-03-29
• B178SBPP102 - Stool Bacterial Pathogens Panel: 2018-03-29 Stool Bacterial Pathogens Panel Cartridge with sample prep device.
• B178GBSTEC102 - Shiga Toxin Direct Test: 2018-03-29Shiga Toxin Direct Test 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