FDA.reportPublic FDA data

LIAISON QuantiFERON TB Gold Plus II

Primary DI
18056771104415
Brand
LIAISON QuantiFERON TB Gold Plus II
Company
Diasorin Inc.
Model
311085
Device description
US manufactured kit
Published
2026-02-20
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
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18056771104415PackageGS12In Commercial Distribution
08056771104418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805677110441518056771104415
08056771104418080567711044188056771104418

GMDN Terms#

Term, Definition table
TermDefinition
Interferon IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple types of interferon in a clinical specimen, using a chemiluminescent immunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
033429783
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056771104418LIAISON QuantiFERON TB Gold Plus II3110852026-02-20
08056771104470LIAISON Control QuantiFERON TB Gold Plus II3110812026-02-20
08056771104401LIAISON QuantiFERON TB Gold Plus II3110802026-02-19
08056771600811ANAFLUOR™16622016-09-24
08056771600828ANAFLUOR™16602016-09-24
08056771600835ANAFLUOR ™16242016-09-24
08056771600842ANAFLUOR™66242016-09-24
08056771600859ANAFAST™ ANA Fluorescent Test System 240 Wells16702016-09-24
08056771600897CT-3 Immunoscreen Fluoro-Kit™17402016-09-24
08056771600903CT-2 Immunoscreen Fluoro-Kit™17412016-09-24
08056771600910RS Fluoro-Kit™19702016-09-24
08056771600927ANAFLUOR™ Combo-Pak18122016-09-24
08056771600934ANA HEp-2 6-well Slide Pack16632016-09-24
08056771600941ANA HEp-2 12-well Slide Pack16612016-09-24
08056771600965CT-3 6-well Slide Pack18012016-09-24
08056771600972CT-2 Slide Pack16312016-09-24
08056771601030Fluorescent Antibody (HEp-2) Conjugate16642016-09-24
08056771600118LIAISON® Control HSV-2 IgG3106212016-09-24
08056771602778LIAISON 25 OH Vitamin D Total Assay 200 test3183602021-04-13
08056771600064LIAISON® 25 OH Vitamin D TOTAL Assay3106002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056771104418LIAISON 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
08056771103572LIAISON® QuantiFERON® SoftwareDIASORIN 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