qUAntify 962X

GUDID 00847661003236

qUAntify Plus Control Bilevel MiniPak (A liquid dipstick and microscopic urine control.)

BIO-RAD LABORATORIES, INC.

Multiple urine analyte IVD, control

• Primary Device ID: 00847661003236
• NIH Device Record Key: fa415700-b8d1-4690-9d31-80a49e8c3b37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: qUAntify
• Version Model Number: 962X
• Catalog Number: 962X
• 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	00847661003236 [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.)