Xpert GBS LB GXGBS-LB-120

GUDID 07332940000806

Xpert GBS LB kit; 120 test kit

CEPHEID

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

• Primary Device ID: 07332940000806
• NIH Device Record Key: f195c0fe-b654-4176-b4ca-a401ab5d32a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xpert GBS LB
• Version Model Number: GXGBS-LB-120
• Catalog Number: GXGBS-LB-120
• Company DUNS: 956711444
• Company Name: CEPHEID
• 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: true
• 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: 1 888 838 3222
• Email: techsupport@cepheid.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332940000806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121539

FDA Product Code

• NJR: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-29

On-Brand Devices [Xpert GBS LB]

• 07332940000882: Xpert GBS LB kit; 10 test kit
• 07332940000806: Xpert GBS LB kit; 120 test kit