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
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
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

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