BD MAX™ Enteric Bacterial Panel (US/CAN) 443378

GUDID 00382904433789

BD MAX™ Enteric Bacterial Panel (US/CAN)

Geneohm Sciences Canada Inc

Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00382904433789
• NIH Device Record Key: d419b0ef-de37-40ba-86ce-f324d7f7dad3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD MAX™ Enteric Bacterial Panel (US/CAN)
• Version Model Number: 443378
• Catalog Number: 443378
• 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
• 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
• 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
• 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
• 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
• 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
• 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	00382904433789 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140111

FDA Product Code

• PCH: Gastrointestinal pathogen panel multiplex nucleic acid-based assay system

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-27

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• 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