FDA.reportPublic FDA data

QbTest

Primary DI
07350103930067
Brand
QbTest
Company
Qbtech AB
Model
QbTest
Published
2023-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LQDRecorder, Attention Task Performance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQDRecorder, Attention Task PerformanceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040894000
K122149000
K133382000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040894000QBTESTQbtech AB2004-06-22LQD
K122149000QBTESQbtech AB2012-10-17LQD
K133382000QB TESTQbtech AB2014-03-24LQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350103930067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350103930067073501039300677350103930067

GMDN Terms#

Term, Definition table
TermDefinition
Psychological assessment softwareA screen-based (non-virtual-reality) software program intended to be used by patients and medical professionals to evaluate and determine the psychological profile of the patient; it may in addition be used to monitor the effectiveness and progress of psychotherapy, however it is not primarily intended to provide interactive therapy. It typically uses psychological tests/questionnaires and patient demographics (e.g., smartphone digital phenotype) to establish a mental wellbeing score, and may also provide resources to promote patient awareness and recovery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
508374720
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350103930012QbCheckQbCheck2023-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011067610DynavisionDynavision Global Holdings, LLCLQD2024-06-10
00860011067627DynavisionDynavision Global Holdings, LLCLQD2024-06-10
00860011067634DynavisionDynavision Global Holdings, LLCLQD2024-06-10
00860011067641DynavisionDynavision Global Holdings, LLCLQD2024-06-10
00860011042105DANA™Anthrotronix, Inc.LQD2023-10-09
07350103930012QbCheckQbtech ABLQD2023-06-14
00862290000302T.O.V.A.TOVA COMPANY, THELQD2020-01-02
00862290000319T.O.V.A.TOVA COMPANY, THELQD2020-01-02
00862290000326T.O.V.A.TOVA COMPANY, THELQD2020-01-02
00862290000333T.O.V.A.TOVA COMPANY, THELQD2020-01-02