ASTar BC G- Frozen insert

GUDID 07350136800078

Antimicrobial Susceptibility Testing - Gram negative

Q-Linea AB

Multiple-type pathogen antimicrobial susceptibility testing kit IVD

• Primary Device ID: 07350136800078
• NIH Device Record Key: f7aeffaa-7415-4215-a072-940b0d83ba60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASTar BC G- Frozen insert
• Version Model Number: 50006671
• Company DUNS: 775813863
• Company Name: Q-Linea AB
• 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 5703168943
• Email: support@qlinea.com
• Phone: +1 5703168943
• Email: support@qlinea.com
• Phone: +1 5703168943
• Email: support@qlinea.com
• Phone: +1 5703168943
• Email: support@qlinea.com
• Phone: +1 5703168943
• Email: support@qlinea.com
• Phone: +1 5703168943
• Email: support@qlinea.com
• Phone: +1 5703168943
• Email: support@qlinea.com
• Phone: +1 5703168943
• Email: support@qlinea.com
• Phone: +1 5703168943
• Email: support@qlinea.com
• Phone: +1 5703168943
• Email: support@qlinea.com
• Phone: +1 5703168943
• Email: support@qlinea.com
• Phone: +1 5703168943
• Email: support@qlinea.com
• Phone: +1 5703168943
• Email: support@qlinea.com
• Phone: +1 5703168943
• Email: support@qlinea.com
• Phone: +1 5703168943
• Email: support@qlinea.com
• Phone: +1 5703168943
• Email: support@qlinea.com
• Phone: +1 5703168943
• Email: support@qlinea.com
• Phone: +1 5703168943
• Email: support@qlinea.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350136800078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221688

FDA Product Code

• SAN: Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-08
• Device Publish Date: 2024-09-30

Devices Manufactured by Q-Linea AB

• 07350136800047 - ASTar Instrument: 2024-10-08 Antimicrobial Susceptibility Testing
• 07350136800054 - ASTar BC G- Kit software: 2024-10-08 Antimicrobial Susceptibility Testing - Gram negative
• 07350136800061 - ASTar BC G- Consumable kit: 2024-10-08 Antimicrobial Susceptibility Testing - Gram negative
• 07350136800078 - ASTar BC G- Frozen insert: 2024-10-08Antimicrobial Susceptibility Testing - Gram negative
• 07350136800078 - ASTar BC G- Frozen insert: 2024-10-08 Antimicrobial Susceptibility Testing - Gram negative