ASTar BC G- Frozen insert

Basic Information

• Brand Name: ASTar BC G- Frozen insert
• Primary DI: 07350136800078
• Version / Model: 50006671
• Company Name: Q-Linea AB
• Labeler DUNS: 775813863
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-30
• Public Version: 1
• Public Version Date: 2024-10-08
• Public Version Status: New
• Public Device Record Key: f7aeffaa-7415-4215-a072-940b0d83ba60

Device Description

Antimicrobial Susceptibility Testing - Gram negative

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SAN	Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples	Microbiology	866.1650	2
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	866.1645	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63870	Multiple-type pathogen antimicrobial susceptibility testing kit IVD	A collection of reagents and other associated materials containing a range of antimicrobial agents e.g., (antibacterial/antibiotic, antifungal/antimycotic and/or antimycobacterial) that may be impregnated on individual testing discs, in a strip format or a microplate, intended to be used to determine the susceptibility profile of a specific pathogen (bacterium, fungus and/or Mycobacterium), in a clinical specimen and/or culture isolate.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350136800078	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K221688	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – -15 Degrees Celsius