Quest Diagnostics 945

GUDID 03610520540930

Quest Diagnostics Serum Chemistry Control Trilevel (A human serum chemistry control.)

BIO-RAD LABORATORIES, INC.

Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: 03610520540930
• NIH Device Record Key: 99536275-84c0-470d-838e-3a07b4c05fa5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quest Diagnostics
• Version Model Number: 945
• Catalog Number: 945
• Company DUNS: 051624070
• Company Name: BIO-RAD LABORATORIES, 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03610520540930 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033387

FDA Product Code

• JJY: Multi-analyte controls, all kinds (assayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-17
• Device Publish Date: 2023-10-09

On-Brand Devices [Quest Diagnostics]

• 03610520540930: Quest Diagnostics Serum Chemistry Control Trilevel (A human serum chemistry control.)
• 03610520540923: Quest Diagnostics Serum Chemistry Control Trilevel (A human serum chemistry control.)
• 03610520540916: Quest Diagnostics Immunoassay/TDM Control (A human serum immunoassay/TDM control.)
• 00847661004080: Quest Diagnostics Tumor Marker Control (A human serum tumor marker control.)