BD Molecular Swab Collection Kit 443925

GUDID 00382904439255

Molecular Swab Collection Kit 100EA

BECTON, DICKINSON AND COMPANY

Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical
Primary Device ID00382904439255
NIH Device Record Key6e376d56-8105-4d8b-bfe3-d465291124fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Molecular Swab Collection Kit
Version Model Number443925
Catalog Number443925
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Peel here
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Peel here
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Peel here
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Peel here
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Peel here
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Peel here
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Peel here
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Peel here
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Peel here
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Peel here
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Peel here
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Peel here
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Peel here
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Special Storage Condition, SpecifyBetween 0 and 0 *Peel here
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *This way up

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904439255 [Primary]
GS130382904439256 [Package]
Package: Case [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PQAVaginitis and bacterial vaginosis nucleic acid detection system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2025-07-31
Device Publish Date2024-02-26

On-Brand Devices [BD Molecular Swab Collection Kit]

30382904439256Molecular Swab Collection Kit 100EA
00382904439255Molecular Swab Collection Kit 100EA

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.