FDA.reportPublic FDA data

BD Molecular Swab Sample Buffer Tubes

Primary DI
00382904402969
Brand
BD Molecular Swab Sample Buffer Tubes
Company
BECTON, DICKINSON AND COMPANY
Model
440296
Catalog number
440296
Device description
Molecular Swab Sample Buffer Tubes 48EA
Published
2024-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MKZDNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKZDna Probe, Nucleic Acid Amplification, ChlamydiaMicrobiology1

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
30382904402960PrimaryGS10
00382904402969Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290440296030382904402960
00382904402969003829044029693829044029690382904402969

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
122561087
Device count
48
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382904439248BD Molecular Urine Transport KitBECTON, DICKINSON AND COMPANYMKZ2024-05-16
30382904402960BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-26
30382904439232BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-23
00382904439231BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-23
15420045511880Aptima®Hologic, Inc.MKZ2023-10-26
00884999051096Alinity mABBOTT MOLECULAR INC.MKZ2023-09-14
00810031720064Visby Medical Sexual Health TestVisby Medical, Inc.MKZ2023-04-19
00810031720071Visby Medical Power Adapter, Right AngleVisby Medical, Inc.MKZ2023-04-19
15420045514966APTIMAHologic, Inc.MKZ2022-07-28
15420045514973APTIMAHologic, Inc.MKZ2022-07-28
00382904439040BD CTGCTV2 for BD MAX™ SystemBECTON, DICKINSON AND COMPANYMKZ2022-07-14
00382904439897BD COR™ MXBECTON, DICKINSON AND COMPANYMKZ2022-06-16
00382904439798BD CTGCTV2BECTON, DICKINSON AND COMPANYMKZ2022-06-08
00884999048898Alinity mABBOTT MOLECULAR INC.MKZ2022-05-18
00884999047686Alinity mABBOTT MOLECULAR INC.MKZ2022-05-18
00884999047693Alinity mABBOTT MOLECULAR INC.MKZ2022-05-18
00884999049314Alinity mABBOTT MOLECULAR INC.MKZ2022-05-18
00810031720002Visby Medical Sexual Health Click TestVisby Medical, Inc.MKZ2021-09-15
00810031720033Visby Medical Power AdapterVisby Medical, Inc.MKZ2021-09-15
00810031720057Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 PackVisby Medical, Inc.MKZ2021-09-15
15420045512818APTIMAHologic, Inc.MKZ2020-06-24
15420045512825APTIMAHologic, Inc.MKZ2020-06-24
15420045512832Aptima Combo 2®Hologic, Inc.MKZ2020-06-16
15420045512849Aptima Combo 2®Hologic, Inc.MKZ2020-06-16
15420045512894Aptima Combo 2®Hologic, Inc.MKZ2020-06-16
15420045512900Aptima Combo 2®Hologic, Inc.MKZ2020-06-16
00382904411268BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA AssayBECTON, DICKINSON AND COMPANYMKZ2018-05-25
00382904429591BD ProbeTec™ Chlamydia trachomatis Qx Assay Gray Amp Reagent PackBECTON, DICKINSON AND COMPANYMKZ2018-05-25
00382904429706BD MAX™ CT/GC/TVBECTON, DICKINSON AND COMPANYMKZ2018-05-25
00875197005776cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 SystemsRoche Molecular Systems, Inc.MKZ2018-04-26