AccessGUDID - DEVICE: FAST PBC Prep Cartridge (B6011002000)

GUDID

Device Identifier (DI) Information

Brand Name: FAST PBC Prep Cartridge
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-02-00
Company Name: Qvella Corporation

Primary DI Number: B6011002000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 251371170 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJH	Clinical Sample Concentrator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 32d84ad7-b90b-4875-8954-41db66379e8b
Public Version Date: April 06, 2023
Public Version Number: 1
DI Record Publish Date: March 29, 2023