FDA.reportPublic FDA data

QuantiFERON-TB Gold Blood Collection Tubes

Primary DI
14053228002144
Brand
QuantiFERON-TB Gold Blood Collection Tubes
Company
QIAGEN SCIENCES INC.
Model
1
Catalog number
T05900301
Device description
Bulk pack
Published
2017-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
P010033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010033000QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBEQiagen2001-11-28NCD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14053228002144PrimaryGS10
04053228002147Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1405322800214414053228002144
04053228002147040532280021474053228002147

GMDN Terms#

Term, Definition table
TermDefinition
T-cell activation/stimulated interferon release IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of reactive T-cells in a clinical specimen which have become activated in response to stimulation by one or multiple specific antigens or mitogens, including (but not limited to) Borrelia species, Epstein-Barr virus (EBV), Cytomegalovirus (CMV), BK virus and/or Mycobacterium species. T-cell activation is detected through the release of interferon gamma (IFN gamma).

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
008675485
Device count
100
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053228047988IGRA Control Set16280222023-12-04
14053228015885QuantiFERON®-TB Gold Plus16224332017-10-02
14053228015892QuantiFERON®-TB Gold Plus16225362017-10-02
14053228015908QuantiFERON®-TB Gold Plus16235362017-10-02
14053228015915QuantiFERON®-TB Gold Plus16234332017-10-02
04053228002109QuantiFERON-TB Gold 2 Plate Kit159402012017-01-04
04053228002116QuantiFERON-TB Gold Reference Lab Pack159405012017-01-04
04053228015864QuantiFERON®-TB Gold Plus16221302017-10-02
04053228015871QuantiFERON®-TB Gold Plus16228322017-10-02
14053228033568QuantiFERON®-TB Gold Plus16225292019-12-18
14053228033575QuantiFERON®-TB Gold Plus16235292019-12-18
14053228002120QuantiFERON-TB Gold Blood Collection Tubes Dispenser Pack 159704032017-01-04
14053228002137QuantiFERON-TB Gold Blood Collection Tubes Dispenser Pack - High Altitude159704052017-01-04
14053228002151QuantiFERON-TB Gold Blood Collection Tubes - High Altitude1T059005052017-01-04
14053228010354digene® HC2 DNA Collection Device16192042016-09-29
04053228010777DML 300015000-000312016-12-21
14053228002014digene® Wash Buffer Concentrate 15100-000472017-01-04
04053228002000hc2 High-Risk HPV DNA Test15199-000162017-01-04
04053228002024hc2 HPV DNA Test15198-12202017-01-04
04053228002031hc2 High-Risk HPV DNA Test15199-12202017-01-04

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
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
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