FDA.reportPublic FDA data

digene® Wash Buffer Concentrate

Primary DI
14053228002014
Brand
digene® Wash Buffer Concentrate
Company
QIAGEN SCIENCES INC.
Model
1
Catalog number
5100-00047
Device description
digene® Wash Buffer Concentrate (paired with 5199-00016 High-risk 4-plate)
Published
2017-01-04
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
MAQKit, Dna Detection, Human Papillomavirus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAQKit, Dna Detection, Human PapillomavirusUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P890064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890064000VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KITQiagen Gaithersburg, Inc.1991-03-11MAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14053228002014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1405322800201414053228002014

GMDN Terms#

Term, Definition table
TermDefinition
Human papillomavirus (HPV) antigen 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 antigens from one or multiple strains of human papillomavirus (HPV) in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008675485
Device count
1
Lot or batch
true
Expiration date on label
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
14053228002144QuantiFERON-TB Gold Blood Collection Tubes1T059003012017-01-04
14053228002151QuantiFERON-TB Gold Blood Collection Tubes - High Altitude1T059005052017-01-04
14053228010354digene® HC2 DNA Collection Device16192042016-09-29
04053228010777DML 300015000-000312016-12-21
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
00884999051287Alinity mABBOTT MOLECULAR INC.MAQ2026-04-13
30382904454167BD Onclarity HPV Self Collection Diluent TubeBECTON, DICKINSON AND COMPANYMAQ2024-11-01
00382904454166BD Onclarity HPV Self Collection Diluent TubeBECTON, DICKINSON AND COMPANYMAQ2024-11-01
30382904454365BD Copan FLOQSwabs for HPV Self CollectionBECTON, DICKINSON AND COMPANYMAQ2024-10-09
00382904454364FLOQSwabs for HPV Self CollectionBECTON, DICKINSON AND COMPANYMAQ2024-10-09
30382904440726BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent TubesBECTON, DICKINSON AND COMPANYMAQ2024-09-13
00382904440725BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent TubesBECTON, DICKINSON AND COMPANYMAQ2024-09-13
30382904440740BD Onclarity™ HPV Extraction Reagent Trough for BD COR™BECTON, DICKINSON AND COMPANYMAQ2024-07-26
00382904440749BD Onclarity™ HPV Extraction Reagent Trough for BD COR™BECTON, DICKINSON AND COMPANYMAQ2024-07-26
00875197006896cobas HPV Positive Control KitRoche Molecular Systems, Inc.MAQ2024-06-06
00875197006889cobas HPVRoche Molecular Systems, Inc.MAQ2024-06-05
00382904440756BD Onclarity™ HPV Assay Reagent PackBECTON, DICKINSON AND COMPANYMAQ2024-04-29
30382904440832BD Onclarity™ HPV Assay Diluent for BD COR™BECTON, DICKINSON AND COMPANYMAQ2024-02-28
00382904440831BD Onclarity™ HPV Assay Diluent for BD COR™BECTON, DICKINSON AND COMPANYMAQ2024-02-28
00382904439880BD COR™ PX INSTRUMENTBECTON, DICKINSON AND COMPANYMAQ2024-02-16
00382904439903BD COR™ GX INSTRUMENTBECTON, DICKINSON AND COMPANYMAQ2024-02-16
00884999048614Alinity mABBOTT MOLECULAR INC.MAQ2024-01-02
00884999048621Alinity mABBOTT MOLECULAR INC.MAQ2024-01-02
00884999048676Alinity mABBOTT MOLECULAR INC.MAQ2024-01-02
30382904453283BD Onclarity™ HPV LBC Diluent TubesBECTON, DICKINSON AND COMPANYMAQ2023-10-26
00382904453282BD Onclarity™ HPV LBC Diluent TubesBECTON, DICKINSON AND COMPANYMAQ2023-10-26
30382904453290BD Onclarity™ HPV SurePath™ Diluent TubesBECTON, DICKINSON AND COMPANYMAQ2023-10-25
00382904453299BD Onclarity™ HPV SurePath™ Diluent TubesBECTON, DICKINSON AND COMPANYMAQ2023-10-25
00875197005752cobas HPV for use on the cobas 6800/8800 systemsRoche Molecular Systems, Inc.MAQ2021-06-04
00875197005769cobas HPV Positive ControlRoche Molecular Systems, Inc.MAQ2021-06-04
00382904419905BD Onclarity™ HPV Assay Reagent PackBECTON, DICKINSON AND COMPANYMAQ2021-04-19
00382904440886BD Control Set for the BD Onclarity™ HPV AssayBECTON, DICKINSON AND COMPANYMAQ2021-03-25
30382904438372BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent TubesBECTON, DICKINSON AND COMPANYMAQ2020-02-19
30382904440870BD Viper™ PCR Extraction Reagent Trough with Piecring ToolBECTON, DICKINSON AND COMPANYMAQ2020-02-19
30382904440894BD FOX™ PCR Extraction TubesBECTON, DICKINSON AND COMPANYMAQ2020-02-19