FDA.reportPublic FDA data

BacterioScan 216Dx System

Primary DI
B9090020
Brand
BacterioScan 216Dx System
Company
BACTERIOSCAN, INC.
Model
Appliance 216DxA4
Device description
Network appliance used in system
Published
2020-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QBQSystem, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBQSystem, Microbial Growth Monitor Of Normally Sterile Body Fluid CultureMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172412000BacterioScan 216Dx SystemBacterioscan, Inc.2018-05-01QBQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B9090020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Microbial incubator/imaging system IVDAn electrically-powered device intended to provide ideal conditions for microbial growth with an incubator, and to capture digital images of the specimens contained within the incubator at specified time intervals. It consists of an incubator unit with multiple shelves, a camera and a display unit for microbial growth monitoring. The system automatically monitors and controls temperature, humidity, and gaseous conditions [e.g., carbon dioxide (CO2) and oxygen (O2) concentrations]. It may have an integrated robotic transfer arm for loading and unloading the incubator onto/from other instruments. The device may be a single unit or modular assembly.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
029599160
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B9090051BacterioScan 216Dx SystemClear Cartridge - 4 Well Tray2020-10-21
B9090052BacterioScan 216Dx SystemClear Cartridge - 4 Well Case2020-10-21
B9090050BacterioScan 216Dx SystemClear Cartridge - 4 Well2020-10-21
B90900511BacterioScan 216Dx SystemClear Cartridge - 4 Well Tray2020-10-21
B90900522BacterioScan 216Dx SystemClear Cartridge - 4 Well Case2020-10-21
B9090010BacterioScan 216Dx System216Dx2020-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B9090051BacterioScan 216Dx SystemBACTERIOSCAN, INC.QBQ2020-10-21
B9090052BacterioScan 216Dx SystemBACTERIOSCAN, INC.QBQ2020-10-21
B9090050BacterioScan 216Dx SystemBACTERIOSCAN, INC.QBQ2020-10-21
B90900511BacterioScan 216Dx SystemBACTERIOSCAN, INC.QBQ2020-10-21
B90900522BacterioScan 216Dx SystemBACTERIOSCAN, INC.QBQ2020-10-21
B9090010BacterioScan 216Dx SystemBACTERIOSCAN, INC.QBQ2020-09-15