FDA.reportPublic FDA data

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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJHClinical Sample Concentrator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B6011002000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
833-478-3552TechSupport@qvella.com

Regulatory Flags#

DUNS number
251371170
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B6011001000FAST Instrument110-01-002023-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B708ABFVR020XCELLAPEX BIOLOGIX , LLCJJH2026-03-26
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06955792702851Nucleic Acid Extraction and Purification Kit 1.0Sansure Biotech Inc.JJH2026-03-25
06955792702868Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702875Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702882Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
06955792702899Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
04053228040576EZ2 Connect MDxQIAGEN GmbHJJH2026-03-03
00849811081835Maxwell® CSC Rapid ccfDNA KitPROMEGA CORPORATIONJJH2026-02-16
00849811083778Maxwell® CSC XtractAll FFPE DNA/RNA KitPROMEGA CORPORATIONJJH2026-02-16
04719882810046IntelliPrep TRIO 240 Sample Preparation SystemPlexBio Co., Ltd.JJH2026-01-28
04719882810237IntelliPrep Blood Genomic DNA Extraction Kit PlexBio Co., Ltd.JJH2026-01-28
04719882810268IntelliPrep FFPE DNA Extraction Kit PlexBio Co., Ltd.JJH2026-01-28
04719882810282IntelliPrep FFPE RNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
04719882810299IntelliPrep cfDNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
04719880121397TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
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