FDA.reportPublic FDA data

BD Molecular Urine Transport Kit

Primary DI
00382904439248
Brand
BD Molecular Urine Transport Kit
Company
BECTON, DICKINSON AND COMPANY
Model
443924
Catalog number
443924
Device description
Molecular Urine Transport Kit 96EA
Published
2024-05-16
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
LSLDNA-REAGENTS, NEISSERIA
MKZDNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA
OUYTrichomonas vaginalis nucleic acid amplification test system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSLDna-Reagents, NeisseriaMicrobiology2
MKZDna Probe, Nucleic Acid Amplification, ChlamydiaMicrobiology1
OUYTrichomonas Vaginalis Nucleic Acid Amplification Test SystemImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182692000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182692000BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company2019-01-08OUY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904439249PrimaryGS10
00382904439248Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290443924930382904439249
00382904439248003829044392483829044392480382904439248

GMDN Terms#

Term, Definition table
TermDefinition
Urine specimen collection kit IVDA collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.

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
00382902780519BD Macro-Vue™ Card Test Rotator2780512780512016-05-19
00885403522324Swan-Ganz151F7151F72026-07-31
00885403523581VAMP48VMP10648VMP1062026-07-31
00885403523598VAMP48VMP12048VMP1202026-07-31
00885403523734VAMP48VMP18448VMP1842026-07-31
00885403524281TruWave, VAMP PlusPXVP1087PXVP10872026-07-31
00885403524694TruWave, VAMP PlusPXVP0550PXVP05502026-07-31
00885403524922TruWavePX266CPX266C2026-07-31
00885403525066TruWave, VAMPPXAVMPPXAVMP2026-07-31
00885403525547TruWave, VAMPPXAVMP3PXAVMP32026-07-31
00885403525608TruWave, VAMPPXVMP172AT3PXVMP172AT32026-07-31
00885403525646TruWave, VAMP PlusPXVP1071PXVP10712026-07-31
00885403529644Acumen IQ CuffAIQCLAIQCL2026-07-31
00885403529651Acumen IQ CuffAIQCMAIQCM2026-07-31
00885403530404Fogarty120404F120404F2026-07-31
00885403530411Fogarty120602F120602F2026-07-31
00885403530428Fogarty120803F120803F2026-07-31
00885403530442Fogarty120804F120804F2026-07-31
00885403530466Fogarty120805F120805F2026-07-31
00885403530565Fogarty12TLW805F3512TLW805F352026-07-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00875197007251cobas® liat CT, NG and MG control kitRoche Molecular Systems, Inc.LSL2026-02-24
00875197007268cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.LSL2026-02-24
00875197007275cobas® liat CT/NGRoche Molecular Systems, Inc.LSL2026-02-24
00382904439767BD Vaginal Panel on BD COR SystemBECTON, DICKINSON AND COMPANYOUY2024-04-02
30382904402960BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-26
30382904402960BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYLSL2024-02-26
30382904402960BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYOUY2024-02-26
00382904402969BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-26
30382904439232BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYLSL2024-02-23
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30382904439232BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-23
00382904439231BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-23
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15420045511880Aptima®Hologic, Inc.LSL2023-10-26
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00884999051096Alinity mABBOTT MOLECULAR INC.MKZ2023-09-14
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00810031720064Visby Medical Sexual Health TestVisby Medical, Inc.LSL2023-04-19
00810031720064Visby Medical Sexual Health TestVisby Medical, Inc.MKZ2023-04-19
10810031720061Visby Medical Sexual Health TestVisby Medical, Inc.LSL2023-04-19
00810031720071Visby Medical Power Adapter, Right AngleVisby Medical, Inc.OUY2023-04-19
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15420045514966APTIMAHologic, Inc.MKZ2022-07-28
15420045514966APTIMAHologic, Inc.LSL2022-07-28
15420045514973APTIMAHologic, Inc.MKZ2022-07-28
15420045514973APTIMAHologic, Inc.LSL2022-07-28
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