Group B Strep Assay GBGBS-10

GUDID B178GBGBS100

GREAT BASIN SCIENTIFIC, INC.

Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: B178GBGBS100
• NIH Device Record Key: 11703581-5ef4-4b63-adf1-78b8b914c66c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Group B Strep Assay
• Version Model Number: GBGBS-10
• Catalog Number: GBGBS-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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B178GBGBS100 [Primary]
HIBCC	B178GBGBS102 [Package]; 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

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