VARIANT II TURBO 2702401

GUDID 00847817013904

VARIANT II TURBO Hemoglobin A1c Program Elution Buffer A

BIO-RAD LABORATORIES, INC.

Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent

• Primary Device ID: 00847817013904
• NIH Device Record Key: 93dd48db-e23c-444e-adef-0544e2f8269f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VARIANT II TURBO
• Version Model Number: 270-2401
• Catalog Number: 2702401
• 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: false
• 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 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847817013904 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040872

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 TURBO]

• 00847817014468: VARIANT II TURBO HbA1c Kit - 2.0 Prefilter
• 00847817014444: VARIANT II TURBO HbA1c Kit - 2.0 Analytical Cartridge
• 00847817014406: VARIANT II TURBO HbA1c Kit - 2.0 Calibrator/Diluent Set
• 00847817014390: VARIANT II TURBO HbA1c Kit - 2.0 Elution Buffer B
• 00847817014383: VARIANT II TURBO HbA1c Kit - 2.0 Elution Buffer A
• 00847817014369: VARIANT II TURBO HbA1c Kit - 2.0
• 00847817014154: VARIANT II TURBO Hemoglobin A1c Program Calibrator/Diluent Set
• 00847817014093: VARIANT II TURBO Hemoglobin A1c Program Guard Cartridge
• 00847817014079: VARIANT II TURBO Hemoglobin A1c Program Analytical Cartridge
• 00847817013966: VARIANT II TURBO Hemoglobin A1c Program Calibrator/Diluent Set
• 00847817013928: VARIANT II TURBO Hemoglobin A1c Program Elution Buffer B
• 00847817013904: VARIANT II TURBO Hemoglobin A1c Program Elution Buffer A
• 00847817000461: VARIANT II TURBO Hemoglobin A1c Wash/Diluent Set
• 00847817000416: VARIANT II TURBO Hemoglobin A1c Program Reorder Pack
• 00847817000409: VARIANT II TURBO Hemoglobin A1c Program Reorder Pack
• 03610520506547: VARIANT II TURBO HbA1c Kit - 2.0