qUAntify 963

GUDID 00847661003243

qUAntify Plus Control Level 1 (A liquid dipstick and microscopic urine control.)

BIO-RAD LABORATORIES, INC.

Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control

• Primary Device ID: 00847661003243
• NIH Device Record Key: d29dfed7-01b0-4210-ae36-84bc5cc29bda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: qUAntify
• Version Model Number: 963
• Catalog Number: 963
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847661003243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042446

FDA Product Code

• JJW: URINALYSIS CONTROLS (ASSAYED AND UNASSAYED)

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: 2020-09-22
• Device Publish Date: 2020-09-14

On-Brand Devices [qUAntify]

• 03610522007998: qUAntify Advance Control Bilevel MiniPak (A liquid urinalysis control.)
• 03610522007981: qUAntify Advance Control Bilevel (A liquid urinalysis control.)
• 00847661003298: qUAntify Control Bilevel MiniPak (A liquid dipstick urine control.)
• 00847661003281: qUAntify Control Bilevel (A liquid dipstick urine control.)
• 00847661003274: qUAntify Plus Control Bilevel (A liquid dipstick and microscopic urine control.)
• 00847661003267: qUAntify Plus Control Bilevel MiniPak (A liquid dipstick and microscopic urine control.)
• 00847661003250: qUAntify Plus Control Level 2 (A liquid dipstick and microscopic urine control.)
• 00847661003243: qUAntify Plus Control Level 1 (A liquid dipstick and microscopic urine control.)
• 00847661003236: qUAntify Plus Control Bilevel MiniPak (A liquid dipstick and microscopic urine control.)
• 00847661003229: qUAntify Plus Control Bilevel (A liquid dipstick and microscopic urine control.)