FDA.reportPublic FDA data

BD COR™ PX INSTRUMENT

Primary DI
00382904439880
Brand
BD COR™ PX INSTRUMENT
Company
BECTON, DICKINSON AND COMPANY
Model
443988
Catalog number
443988
Device description
BD COR PX INSTRUMENT
Published
2024-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
P160037005

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160037005BD ONCLARITY HPV ASSAYBecton, Dickinson and Company2018-02-12MAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904439880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904439880003829044398803829044398800382904439880

GMDN Terms#

Term, Definition table
TermDefinition
Specimen processing instrument IVDAn electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50382905167015BD Intelliport5167015167012020-09-30
00382905167508BD Intelliport5167505167502020-09-30
00382905168031BD Intelliport System5168035168032024-06-07
00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

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
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
00382904429577BD Viper™ LT System PCR Tube/Tray KitBECTON, DICKINSON AND COMPANYMAQ2020-02-19