BD MAX™ MRSA 442953

GUDID 00382904429539

BD MAX™ MRSA

Geneohm Sciences Canada Inc

MRSA nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00382904429539
• NIH Device Record Key: 07360350-88a0-4d53-9b8d-9e8d51f930be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD MAX™ MRSA
• Version Model Number: 442953
• Catalog Number: 442953
• Company DUNS: 255438483
• Company Name: Geneohm Sciences Canada Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904429539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120138

FDA Product Code

• NQX: SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-07-27

Devices Manufactured by Geneohm Sciences Canada Inc

• 00382904438128 - BD MAX™ Extended Enteric Bacterial Panel: 2019-02-04 BD MAX™ Extended Enteric Bacterial Panel
• 30382904375196 - BD MAX™ PCR Cartridge: 2019-01-23 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 Kit: 2019-01-23 BD GeneOhm™ MRSA ACP Lysis Kit
• 00382904416393 - BD GeneOhm™ MRSA ACP Assay: 2019-01-23 BD GeneOhm™ MRSA ACP Assay (200 tests)
• 00382904429539 - BD MAX™ MRSA: 2019-01-23BD MAX™ MRSA
• 00382904429539 - BD MAX™ MRSA: 2019-01-23 BD MAX™ MRSA
• 00382904434618 - BD MAX™ MRSA XT: 2019-01-23 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 Kit: 2018-07-06 BD MAX™ UVE Specimen Collection Kit Contains: 100 each Sterile polyester-tipped collector swab, transfer pipette, UVE Sample b