VARIANT nbs 2503004

GUDID 00847817008313

VARIANT nbs Sickle Cell Program Retention Time Marker Set

BIO-RAD LABORATORIES, INC.

Inherited haemoglobinopathy IVD, control

• Primary Device ID: 00847817008313
• NIH Device Record Key: da8fe47c-b079-48fe-8ab7-faffdc92e87a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VARIANT nbs
• Version Model Number: 250-3004
• Catalog Number: 2503004
• Company DUNS: 132528295
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847817008313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051072

FDA Product Code

• GKA: ABNORMAL HEMOGLOBIN QUANTITATION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-23
• Device Publish Date: 2016-09-12

On-Brand Devices [VARIANT nbs]

• 00847817008351: VARIANT nbs Sickle Cell Program Whole Blood Primer
• 00847817008344: VARIANT nbs Sickle Cell Program Wash Solution
• 00847817008313: VARIANT nbs Sickle Cell Program Retention Time Marker Set
• 00847817008306: VARIANT nbs Sickle Cell Program Analytical Cartridge
• 00847817008283: VARIANT nbs Sickle Cell Program Elution Buffer 1
• 00847817008276: VARIANT nbs Sickle Cell Program Reorder Pack
• 00847817007354: VARIANT nbs Sickle Cell Program Elution Buffer 2