FDA.reportPublic FDA data

BD COR CTGCTV2 US

Primary DI
00382904454357
Brand
BD COR CTGCTV2 US
Company
BECTON, DICKINSON AND COMPANY
Model
445435
Catalog number
445435
Device description
BD COR CTGCTV2 US
Published
2025-10-21
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
QEPNucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted InfectionsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243343000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243343000BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,2025-04-22QEP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904454357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904454357003829044543573829044543570382904454357

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type 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
Special Storage Condition, Specify00Fragile, handle with care
Special Storage Condition, Specify00This way up
Storage Environment Temperature2 Degrees Celsius27 Degrees Celsius

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
00382905167065BD Intelliport5167065167062020-09-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00875197006056cobas® TV/MGRoche Molecular Systems, Inc.QEP2026-02-24
00875197006063cobas® TV/MG Positive Control KitRoche Molecular Systems, Inc.QEP2026-02-24
00875197006902cobas® TV/MGRoche Molecular Systems, Inc.QEP2026-02-24
00875197006919cobas® TV/MG Positive Control KitRoche Molecular Systems, Inc.QEP2026-02-24
00810031720125Visby Medical Men’s Sexual Health TestVisby Medical, Inc.QEP2025-10-23
05060441760050binx ioBINX HEALTH LIMITEDQEP2025-09-03
25060441760054binx ioBINX HEALTH LIMITEDQEP2025-09-03
00884999051096Alinity mABBOTT MOLECULAR INC.QEP2023-09-14
15420045514966APTIMAHologic, Inc.QEP2022-07-28
15420045514973APTIMAHologic, Inc.QEP2022-07-28
15420045514980APTIMAHologic, Inc.QEP2022-07-28
15420045514997APTIMAHologic, Inc.QEP2022-07-28
15420045515000APTIMAHologic, Inc.QEP2022-07-28
15420045515017APTIMAHologic, Inc.QEP2022-07-28
00382904439897BD COR™ MXBECTON, DICKINSON AND COMPANYQEP2022-06-16
00382904439798BD CTGCTV2BECTON, DICKINSON AND COMPANYQEP2022-06-08
00884999048591Alinity mABBOTT MOLECULAR INC.QEP2022-05-19
00884999048607Alinity mABBOTT MOLECULAR INC.QEP2022-05-19
00884999048669Alinity mABBOTT MOLECULAR INC.QEP2022-05-19
00884999048898Alinity mABBOTT MOLECULAR INC.QEP2022-05-18
00884999047686Alinity mABBOTT MOLECULAR INC.QEP2022-05-18
00884999047693Alinity mABBOTT MOLECULAR INC.QEP2022-05-18
00884999049314Alinity mABBOTT MOLECULAR INC.QEP2022-05-18
15420045512795APTIMAHologic, Inc.QEP2020-06-24
15420045512801APTIMAHologic, Inc.QEP2020-06-24
15420045512832Aptima Combo 2®Hologic, Inc.QEP2020-06-16
15420045512849Aptima Combo 2®Hologic, Inc.QEP2020-06-16
15420045512894Aptima Combo 2®Hologic, Inc.QEP2020-06-16
15420045512900Aptima Combo 2®Hologic, Inc.QEP2020-06-16
15420045509146Aptima®HOLOGIC LTD.QEP2019-01-25