VARIANT II Hemoglobin A1c 2702425

GUDID 00847817014185

VARIANT II Hemoglobin A1c Program Prefilter

BIO-RAD LABORATORIES, INC.

Glycated haemoglobin (HbA1c) IVD, reagent

• Primary Device ID: 00847817014185
• NIH Device Record Key: 2a8d7e22-fea6-41a7-9759-8ec61d0af698
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VARIANT II Hemoglobin A1c
• Version Model Number: 270-2425
• Catalog Number: 2702425
• 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: false
• 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 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847817014185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070452

FDA Product Code

• LCP: ASSAY, GLYCOSYLATED HEMOGLOBIN

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 II Hemoglobin A1c]

• 00847817014185: VARIANT II Hemoglobin A1c Program Prefilter
• 00847817011979: VARIANT II Hemoglobin A1c Program Calibrator/Diluent Set
• 00847817011955: VARIANT II Hemoglobin A1c Program Analytical Cartridge
• 00847817011948: VARIANT II Hemoglobin A1c Program Wash/Diluent Solution
• 00847817011931: VARIANT II Hemoglobin A1c Program Elution Buffer B
• 00847817011924: VARIANT II Hemoglobin A1c Program Elution Buffer A
• 00847817000324: VARIANT II Hemoglobin A1c Program Reorder Pack