BD MAX™ UVE Specimen Collection Kit 443376

GUDID 30382904433766

BD MAX™ UVE Specimen Collection Kit Contains: 100 each Sterile polyester-tipped collector swab, transfer pipette, UVE Sample buffer tube

Geneohm Sciences Canada Inc

Urogenital specimen transport medium collection kit Urogenital specimen transport medium collection kit Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, transport medium Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical
Primary Device ID30382904433766
NIH Device Record Key8ea93389-6307-4900-909d-7ca3064ed18b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD MAX™ UVE Specimen Collection Kit
Version Model Number443376
Catalog Number443376
Company DUNS255438483
Company NameGeneohm Sciences Canada Inc
Device Count100
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
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 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904433765 [Unit of Use]
GS130382904433766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OUYTrichomonas vaginalis nucleic acid amplification test system

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-17

Devices Manufactured by Geneohm Sciences Canada Inc

00382904438128 - BD MAX™ Extended Enteric Bacterial Panel2019-02-04 BD MAX™ Extended Enteric Bacterial Panel
30382904375196 - BD MAX™ PCR Cartridge2019-01-23 Cartridge BD Max PCR 24 EA
00382904416379 - BD GeneOhm™ MRSA ACP Assay (48 tests)2019-01-23 BD GeneOhm™ MRSA ACP Assay (48 tests)
00382904416386 - BD GeneOhm™ MRSA ACP Lysis Kit2019-01-23 BD GeneOhm™ MRSA ACP Lysis Kit
00382904416393 - BD GeneOhm™ MRSA ACP Assay2019-01-23 BD GeneOhm™ MRSA ACP Assay (200 tests)
00382904429539 - BD MAX™ MRSA2019-01-23 BD MAX™ MRSA
00382904434618 - BD MAX™ MRSA XT2019-01-23 BD MAX™ MRSA XT Contains 24 Master Mix, 24 Extraction Tubes, 24 1.5 mL Sample Buffer Tubes, 25 Septum Caps, 24 Strips Cont
30382904433766 - BD MAX™ UVE Specimen Collection Kit2018-07-06BD MAX™ UVE Specimen Collection Kit Contains: 100 each Sterile polyester-tipped collector swab, transfer pipette, UVE Sample buffer tube
30382904433766 - BD MAX™ UVE Specimen Collection Kit2018-07-06 BD MAX™ UVE Specimen Collection Kit Contains: 100 each Sterile polyester-tipped collector swab, transfer pipette, UVE Sample b

Trademark Results [BD MAX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BD MAX
BD MAX
88922910 not registered Live/Pending
Becton, Dickinson and Company
2020-05-19
BD MAX
BD MAX
77749086 3931753 Live/Registered
BECTON DICKINSON INFUSION THERAPY SYSTEM
2009-06-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.