FDA.reportPublic FDA data

LIAISON® QuantiFERON® Software

Primary DI
08056771103572
Brand
LIAISON® QuantiFERON® Software
Company
DIASORIN SPA
Model
Q0001
Published
2019-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NCDTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NCDTest, Immunity, Cell Mediated, Mycobacterium TuberculosisUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P180047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180047000LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON SoftwareDiaSorin, Inc.2019-11-26NCD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056771103572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056771103572080567711035728056771103572

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDA software program intended to be used with an in vitro diagnostic instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser), or a data management device connected to the IVD instrument/analyser, to facilitate user-controlled device function and/or data processing, display, or communication (e.g., image conversion, incubation control).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
630822989
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056771100625LIAISON® VZV IgG3104952016-09-24
08056771100632LIAISON® Control VZV IgG3104962016-09-24
08056771103015LIAISON BRAHMS PCT II GEN3180902018-04-05
08056771104265LIAISON® XL MUREX Anti-HDV3182602026-01-12
08056771104272LIAISON® XL MUREX Control Anti-HDV3182612026-01-12
08056771100199LIAISON® anti-HAV3102002016-09-24
08056771100205LIAISON® Control anti-HAV3102012016-09-24
08056771100571LIAISON® Rubella IgG3104602016-09-24
08056771100588LIAISON® Rubella IgG TRI-Controls3104612016-09-24
08056771100618LIAISON® Treponema Assay3104802016-09-24
08056771102148LIAISON® XLI00502016-09-24
08056771101943LIAISON® CMV IgM3107502016-09-24
08056771102872LIAISON MDXMOL10012017-04-04
08056771102889LIAISON MDXMOL10112017-04-04
08056771103268LIAISON Quantiferon TB Gold Plus3110202019-12-09
08056771104029LIAISON® Biotrin Parvovirus B19 IgG Plus3115502024-04-08
08056771104036LIAISON® Biotrin Control Parvovirus B19 IgG Plus3115512024-04-08
08056771104166LIAISON® VZV IgG HT 3118702024-03-15
08056771104173LIAISON® Control VZV IgG HT 3118712024-03-15
08056771104098LIAISON QUANTIferon TB Gold Plus3110402023-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056771104418LIAISON QuantiFERON TB Gold Plus IIDiasorin Inc.NCD2026-02-20
18056771104415LIAISON QuantiFERON TB Gold Plus IIDiasorin Inc.NCD2026-02-20
08056771104470LIAISON Control QuantiFERON TB Gold Plus IIDiasorin Inc.NCD2026-02-20
08056771104401LIAISON QuantiFERON TB Gold Plus IIDiasorin Inc.NCD2026-02-19
08056771104098LIAISON QUANTIferon TB Gold PlusDIASORIN SPANCD2023-12-14
08056771104081LIAISON QUANTIferon TB Gold PlusDIASORIN SPANCD2023-09-08
08056771602945LIAISON QUANTIferon TB Gold PlusDiasorin Inc.NCD2023-09-08
08056771602952LIAISON Control QUANTIferon TB Gold PlusDiasorin Inc.NCD2023-09-08
08056771603300LIAISON QUANTIferon TB Gold PlusDiasorin Inc.NCD2023-07-21
14053228033568QuantiFERON®-TB Gold PlusQIAGEN SCIENCES INC.NCD2019-12-18
14053228033575QuantiFERON®-TB Gold PlusQIAGEN SCIENCES INC.NCD2019-12-18
08056771103268LIAISON Quantiferon TB Gold PlusDIASORIN SPANCD2019-12-09
08056771103275LIAISON® Control QuantiFERON®-TB Gold PlusDIASORIN SPANCD2019-12-09
14053228015885QuantiFERON®-TB Gold PlusQIAGEN SCIENCES INC.NCD2017-10-02
14053228015892QuantiFERON®-TB Gold PlusQIAGEN SCIENCES INC.NCD2017-10-02
14053228015908QuantiFERON®-TB Gold PlusQIAGEN SCIENCES INC.NCD2017-10-02
14053228015915QuantiFERON®-TB Gold PlusQIAGEN SCIENCES INC.NCD2017-10-02
04053228015864QuantiFERON®-TB Gold PlusQIAGEN SCIENCES INC.NCD2017-10-02
04053228015871QuantiFERON®-TB Gold PlusQIAGEN SCIENCES INC.NCD2017-10-02
14053228002120QuantiFERON-TB Gold Blood Collection Tubes Dispenser Pack QIAGEN SCIENCES INC.NCD2017-01-04
14053228002137QuantiFERON-TB Gold Blood Collection Tubes Dispenser Pack - High AltitudeQIAGEN SCIENCES INC.NCD2017-01-04
14053228002144QuantiFERON-TB Gold Blood Collection TubesQIAGEN SCIENCES INC.NCD2017-01-04
14053228002151QuantiFERON-TB Gold Blood Collection Tubes - High AltitudeQIAGEN SCIENCES INC.NCD2017-01-04
04053228002109QuantiFERON-TB Gold 2 Plate KitQIAGEN SCIENCES INC.NCD2017-01-04
04053228002116QuantiFERON-TB Gold Reference Lab PackQIAGEN SCIENCES INC.NCD2017-01-04