VARIANT II TURBO 270-2404

GUDID 00847817013966

VARIANT II TURBO Hemoglobin A1c Program Calibrator/Diluent Set

BIO-RAD LABORATORIES, INC.

Glycated haemoglobin (HbA1c) IVD, calibrator

• Primary Device ID: 00847817013966
• NIH Device Record Key: bae6c43c-8a1d-4f31-a488-fa75a675eadc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VARIANT II TURBO
• Version Model Number: 270-2404
• Catalog Number: 270-2404
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847817013966 [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: 3
• Public Version Date: 2018-07-06
• 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