FDA.reportPublic FDA data

BD Molecular LBC Sample Buffer Tubes

Primary DI
30382904439232
Brand
BD Molecular LBC Sample Buffer Tubes
Company
BECTON, DICKINSON AND COMPANY
Model
443923
Catalog number
443923
Device description
Molecular LBC Sample Buffer Tubes 48EA
Published
2024-02-23
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
30382904439232PrimaryGS10
00382904439231Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290443923230382904439232
00382904439231003829044392313829044392310382904439231

GMDN Terms#

Term, Definition table
TermDefinition
Sexually transmitted infection (STI) testing specimen collection kit IVD, clinicalA collection of devices intended exclusively for professional use to collect a clinical specimen at the point-of-care for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis and human immunodeficiency virus (HIV)]. It consists of one or multiple transport containers, with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)], and sampling/collection tool(s) [e.g., vaginal, rectal or oropharyngeal swab, brush, spatula, lancet, pipette]. This is a single-use device.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
122561087
Device count
48
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885403530534Fogarty12TLW404F12TLW404F2026-08-14
00885403530541Fogarty12TLW803F12TLW803F2026-08-14
00885403530558Fogarty12TLW804F12TLW804F2026-08-14
00885403530572Fogarty12TLW806F12TLW806F2026-08-14
00885403530589FOGARTY12TLW807F12TLW807F2026-08-14
00382904411244BD ProbeTec™ (GC) Qx Amplified DNA Assay4411244411242016-07-07
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

Other Devices Sharing Product Codes#

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
00382904439248BD Molecular Urine Transport KitBECTON, DICKINSON AND COMPANYOUY2024-05-16
00382904439248BD Molecular Urine Transport KitBECTON, DICKINSON AND COMPANYMKZ2024-05-16
00382904439248BD Molecular Urine Transport KitBECTON, DICKINSON AND COMPANYLSL2024-05-16
00382904439767BD Vaginal Panel on BD COR SystemBECTON, DICKINSON AND COMPANYOUY2024-04-02
30382904402960BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYLSL2024-02-26
30382904402960BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYOUY2024-02-26
30382904402960BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-26
00382904402969BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-26
00382904439231BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-23
15420045511880Aptima®Hologic, Inc.LSL2023-10-26
15420045511880Aptima®Hologic, Inc.MKZ2023-10-26
00884999051096Alinity mABBOTT MOLECULAR INC.MKZ2023-09-14
00884999051096Alinity mABBOTT MOLECULAR INC.OUY2023-09-14
00884999051096Alinity mABBOTT MOLECULAR INC.LSL2023-09-14
00810031720064Visby Medical Sexual Health TestVisby Medical, Inc.MKZ2023-04-19
00810031720064Visby Medical Sexual Health TestVisby Medical, Inc.LSL2023-04-19
00810031720064Visby Medical Sexual Health TestVisby Medical, Inc.OUY2023-04-19
10810031720061Visby Medical Sexual Health TestVisby Medical, Inc.LSL2023-04-19
00810031720071Visby Medical Power Adapter, Right AngleVisby Medical, Inc.MKZ2023-04-19
00810031720071Visby Medical Power Adapter, Right AngleVisby Medical, Inc.OUY2023-04-19
00810031720071Visby Medical Power Adapter, Right AngleVisby Medical, Inc.LSL2023-04-19
15420045514966APTIMAHologic, Inc.LSL2022-07-28
15420045514966APTIMAHologic, Inc.MKZ2022-07-28
15420045514973APTIMAHologic, Inc.LSL2022-07-28
15420045514973APTIMAHologic, Inc.MKZ2022-07-28
15420045514980APTIMAHologic, Inc.OUY2022-07-28
15420045514997APTIMAHologic, Inc.OUY2022-07-28