BD MAX™ MRSA 442953

GUDID 00382904429539

BD MAX™ MRSA

Geneohm Sciences Canada Inc

MRSA nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00382904429539
NIH Device Record Key07360350-88a0-4d53-9b8d-9e8d51f930be
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD MAX™ MRSA
Version Model Number442953
Catalog Number442953
Company DUNS255438483
Company NameGeneohm Sciences Canada Inc
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904429539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQXSYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-23
Device Publish Date2016-07-27

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™ MRSA2019-01-23BD MAX™ MRSA
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 Kit2018-07-06 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

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