FDA.reportPublic FDA data

BD Molecular Swab Collection Kit

Primary DI
00382904439255
Brand
BD Molecular Swab Collection Kit
Company
BECTON, DICKINSON AND COMPANY
Model
443925
Catalog number
443925
Device description
Molecular Swab Collection Kit 100EA
Published
2024-02-26
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
PQAVaginitis and bacterial vaginosis nucleic acid detection system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201017000BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitGeneohm Sciences Canada, Inc. (Bd Life Sciences)2021-10-18PQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904439256PackageGS1100In Commercial Distribution
00382904439255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290443925630382904439256
00382904439255003829044392553829044392550382904439255

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
Special Storage Condition, Specify00Peel here
Special Storage Condition, Specify00This way up
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15420045517059Aptima®Hologic, Inc.PQA2024-12-19
15420045517066Aptima®Hologic, Inc.PQA2024-12-19
15420045517073Aptima®Hologic, Inc.PQA2024-12-19
15420045517080Aptima®Hologic, Inc.PQA2024-12-19
00382904439767BD Vaginal Panel on BD COR SystemBECTON, DICKINSON AND COMPANYPQA2024-04-02
30382904439256BD Molecular Swab Collection KitBECTON, DICKINSON AND COMPANYPQA2024-02-26
07332940007072Xpert®CEPHEIDPQA2022-04-13
07332940008345Xpert®CEPHEIDPQA2022-04-12
15420045512023Aptima®Hologic, Inc.PQA2019-07-02
15420045512030Aptima®Hologic, Inc.PQA2019-07-02
15420045512047Aptima®Hologic, Inc.PQA2019-07-02
15420045512054Aptima®Hologic, Inc.PQA2019-07-02
15420045512061Aptima®Hologic, Inc.PQA2019-07-02
15420045512078Aptima®Hologic, Inc.PQA2019-07-02
15420045512085Aptima®Hologic, Inc.PQA2019-07-02
15420045512092Aptima®Hologic, Inc.PQA2019-07-02
00382904437121BD MAX™ Vaginal PanelBECTON, DICKINSON AND COMPANYPQA2017-03-23