FDA.reportPublic FDA data

BD Onclarity™ HPV Assay Reagent Pack

Primary DI
00382904419905
Brand
BD Onclarity™ HPV Assay Reagent Pack
Company
BECTON, DICKINSON AND COMPANY
Model
441990
Catalog number
441990
Device description
BD Onclarity™ HPV Assay Reagent Pack
Published
2021-04-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
P160037000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160037000BD ONCLARITY HPV ASSAYBecton, Dickinson and Company2018-02-12MAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904419905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904419905003829044199053829044199050382904419905

GMDN Terms#

Term, Definition table
TermDefinition
Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple strains of human papillomavirus (HPV) in a clinical specimen, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius33 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382903935314Nexiva3935313935312026-07-30
00382903935321Nexiva3935323935322026-07-30
00382903935338Nexiva3935333935332026-07-30
00382903935345Nexiva3935343935342026-07-30
00382903935352Nexiva3935353935352026-07-30
00382903935369Nexiva3935363935362026-07-30
00382903935376Nexiva3935373935372026-07-30
00382903935383Nexiva3935383935382026-07-30
00885403523000FOGARTY SOFTJAWCSOFT6CSOFT62026-07-30
00885403523161FOGARTY HYDRAJAWHYDRA33HYDRA332026-07-30
00885403523253FOGARTY SOFTJAWSOFT33SOFT332026-07-30
00885403523277FOGARTY SOFTJAWSOFT86SOFT862026-07-30
00885403529637Acumen IQAIQCAAIQCA2026-07-29
00885403529668Acumen IQAIQCSAIQCS2026-07-29
00885403529774ClearSight JrCSCJR1CSCJR12026-07-29
00885403529781ClearSightCSCLCSCL2026-07-29
00885403529798ClearSightCSCMCSCM2026-07-29
00885403529811ClearSightCSCSCSCS2026-07-29
00885403529828VitaWaveVWCAVWCA2026-07-29
00885403522393Swan-Ganz834F75834F752026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884999051928Alinity mABBOTT MOLECULAR INC.MAQ2026-07-27
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
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