BD ProbeTec™ ET Instrument, U.S. 440478

GUDID 00382904404789

BD ProbeTec™ ET Instrument, U.S.

BECTON, DICKINSON AND COMPANY

Fluorescent immunoassay analyser IVD, laboratory, automated

• Primary Device ID: 00382904404789
• NIH Device Record Key: ebc4636b-a731-4bc8-8a69-c1de70997267
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD ProbeTec™ ET Instrument, U.S.
• Version Model Number: 440478
• Catalog Number: 440478
• Company DUNS: 122561087
• Company Name: BECTON, DICKINSON AND COMPANY
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Dimensions

• Depth: 28.5 Inch
• Depth: 28.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch
• Width: 28.5 Inch
• Height: 21.5 Inch
• Depth: 28.5 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 33 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904404789 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984631

FDA Product Code

• LSL: DNA-REAGENTS, NEISSERIA

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: 2016-05-19

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