FAST PBC Prep Cartridge

Basic Information

• Brand Name: FAST PBC Prep Cartridge
• Primary DI: B6011002000
• Version / Model: 1
• Catalog Number: 10-02-00
• Company Name: Qvella Corporation
• Labeler DUNS: 251371170
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-29
• Public Version: 1
• Public Version Date: 2023-04-06
• Public Version Status: New
• Public Device Record Key: 32d84ad7-b90b-4875-8954-41db66379e8b

Device Description

The FAST™ System and FAST PBC Prep Cartridge are intended for the automated isolation and concentration of a suspension of bacterial cells from positive blood culture (PBC) bottles for in vitro diagnostic use. The FAST™ System and FAST PBC Prep Cartridge have not been validated for any downstream diagnostic procedures or applications and are only indicated for positive blood culture specimens containing bacteria. The FAST PBC Prep Cartridge is only for use with the FAST™ System. The FAST™ System and FAST PBC Prep Cartridge are intended for use by trained and qualified laboratory personnel.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
JJH	Clinical Sample Concentrator	Clinical Chemistry	862.2310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17452	Microsample centrifuge IVD	An electrically-powered device intended to be used mainly in the clinical laboratory to centrifuge small sample volumes (typically from 0.25 to 2.2 ml) through centrifugal force. It is typically a compact stationary structure with an electric motor, a rotor, a shaft, and speed and time controls. It may include a vortex mixing function and/or refrigerating capabilities to keep cool the rotor chamber or to perform temperature sensitive procedures. The device is intended to spin down microorganisms, cells, precipitates, or reagent solutions prior to subsequent in vitro diagnostic procedures; it may also sediment viruses and cellular organelles.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B6011002000	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius