FDA.report

FAST PBC Prep Cartridge

Primary DI
B6011002000
Brand
FAST PBC Prep Cartridge
Company
Qvella Corporation
Model
1
Catalog number
10-02-00
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.
Published
2023-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JJHClinical Sample Concentrator

Product Code Classifications

CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B6011002000PrimaryHIBCC0

GMDN Terms

TermDefinition
Microsample centrifuge IVDAn 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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
833-478-3552TechSupport@qvella.com

Regulatory Flags

DUNS number
251371170
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B6011001000FAST Instrument110-01-002023-03-29

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