FDA.reportPublic FDA data

BD MAX™ CT/GC/TV

Primary DI
00382904438241
Brand
BD MAX™ CT/GC/TV
Company
Geneohm Sciences Canada Inc
Model
443824
Catalog number
443824
Device description
Kit BD Max CT/GC/TV US
Published
2016-10-17
Public version status
Update
Distribution status
Not 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
OUYTrichomonas vaginalis nucleic acid amplification test system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUYTrichomonas Vaginalis Nucleic Acid Amplification Test SystemImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151589000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151589000BD MAX CT/GC/TV, BD MAX INSTRUMENTBecton, Dickinson and Company2016-09-06OUY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904438241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904438241003829044382413829044382410382904438241

GMDN Terms#

Term, Definition table
TermDefinition
Multiple sexually transmitted pathogen 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 multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
255438483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382904433789BD MAX™ Enteric Bacterial Panel (US/CAN)4433784433782016-07-27
00382904375065BD MAX™ RNA-34375064375062018-05-25
00382904429539BD MAX™ MRSA4429534429532016-07-27
00382904416652BD GeneOhm™ VanR Assay4416654416652016-05-19
00382904433802BD MAX™ Enteric Parasite Panel (US/CAN)4433804433802016-05-19
00382904414481BD GeneOhm™ StaphSR assay 48 TestsA4414484414482016-08-10
00382904416379BD GeneOhm™ MRSA ACP Assay (48 tests)4416374416372016-08-09
00382904416386BD GeneOhm™ MRSA ACP Lysis Kit4416384416382016-08-10
00382904416393BD GeneOhm™ MRSA ACP Assay4416394416392016-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382904439248BD Molecular Urine Transport KitBECTON, DICKINSON AND COMPANYOUY2024-05-16
00382904439767BD Vaginal Panel on BD COR SystemBECTON, DICKINSON AND COMPANYOUY2024-04-02
30382904402960BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYOUY2024-02-26
30382904439232BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYOUY2024-02-23
00884999051096Alinity mABBOTT MOLECULAR INC.OUY2023-09-14
00810031720064Visby Medical Sexual Health TestVisby Medical, Inc.OUY2023-04-19
00810031720071Visby Medical Power Adapter, Right AngleVisby Medical, Inc.OUY2023-04-19
15420045514980APTIMAHologic, Inc.OUY2022-07-28
15420045514997APTIMAHologic, Inc.OUY2022-07-28
15420045515000APTIMAHologic, Inc.OUY2022-07-28
15420045515017APTIMAHologic, Inc.OUY2022-07-28
00382904439040BD CTGCTV2 for BD MAX™ SystemBECTON, DICKINSON AND COMPANYOUY2022-07-14
00382904439897BD COR™ MXBECTON, DICKINSON AND COMPANYOUY2022-06-16
00382904439798BD CTGCTV2BECTON, DICKINSON AND COMPANYOUY2022-06-08
00884999048898Alinity mABBOTT MOLECULAR INC.OUY2022-05-18
00884999047686Alinity mABBOTT MOLECULAR INC.OUY2022-05-18
00884999047693Alinity mABBOTT MOLECULAR INC.OUY2022-05-18
00884999049314Alinity mABBOTT MOLECULAR INC.OUY2022-05-18
00810031720002Visby Medical Sexual Health Click TestVisby Medical, Inc.OUY2021-09-15
00810031720033Visby Medical Power AdapterVisby Medical, Inc.OUY2021-09-15
00810031720057Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 PackVisby Medical, Inc.OUY2021-09-15
07332940002954Xpert Urine Specimen Collection KitCEPHEIDOUY2018-07-02
00382904429706BD MAX™ CT/GC/TVBECTON, DICKINSON AND COMPANYOUY2018-05-25
07332940001001Xpert TVCEPHEIDOUY2018-01-29
00382904437121BD MAX™ Vaginal PanelBECTON, DICKINSON AND COMPANYOUY2017-03-23
30382904433766BD MAX™ UVE Specimen Collection KitBECTON, DICKINSON AND COMPANYOUY2016-10-17
30382904434206BD MAX™ UVE Sample Buffer TubesBECTON, DICKINSON AND COMPANYOUY2016-10-17
30014613336396SolanaQUIDEL CORPORATIONOUY2016-09-16
30014613336402SolanaQUIDEL CORPORATIONOUY2016-09-16
30014613312116AmpliVueQUIDEL CORPORATIONOUY2016-09-15