Multiqual 695X

GUDID 00847661001928

Liquid Assayed Multiqual MiniPak (A human serum assayed chemistry control.)

BIO-RAD LABORATORIES, INC.

Multiple clinical chemistry analyte IVD, control

• Primary Device ID: 00847661001928
• NIH Device Record Key: df088825-a5a8-486b-9fc6-57b5d21c7a3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multiqual
• Version Model Number: 695X
• Catalog Number: 695X
• 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847661001928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043208

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

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• 00847661001928: Liquid Assayed Multiqual MiniPak (A human serum assayed chemistry control.)
• 00847661001324: Liquid Unassayed Multiqual Level 3 (A human serum unassayed chemistry control.)
• 00847661001317: Liquid Unassayed Multiqual Level 2 (A human serum unassayed chemistry control.)
• 00847661001300: Liquid Unassayed Multiqual Level 1 (A human serum unassayed chemistry control.)
• 00847661001294: Liquid Assayed Multiqual Level 3 (A human serum assayed chemistry control.)
• 00847661001287: Liquid Assayed Multiqual Level 2 (A human serum assayed chemistry control.)
• 00847661001270: Liquid Assayed Multiqual Level 1 (A human serum assayed chemistry control.)