D-100 2901012

GUDID 00847817016035

D-100 Wash Solution

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 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 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 Glycated haemoglobin (HbA1c) IVD, reagent

• Primary Device ID: 00847817016035
• NIH Device Record Key: ecd61b19-635c-45b6-ba4c-c3b9589a69e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-100
• Version Model Number: 290-1012
• Catalog Number: 2901012
• 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
• 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
• 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
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847817016035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151321

FDA Product Code

• PDJ: Hemoglobin A1c test system

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-23
• Device Publish Date: 2016-09-12

On-Brand Devices [D-100]

• 00847817025693: D-100 Prefilter
• 00847817025679: D-100 HbA1c Elution Buffer A
• 00847817020155: D-100 HbA1c Calibrator Pack
• 00847817016035: D-100 Wash Solution
• 00847817016028: D-100 HbA1c Elution Buffer B
• 00847817016004: D-100 Sample Diluent
• 00847817015991: D-100 Cleaning Tube
• 00847817015953: D-100 HbA1c Analytical Cartridge/Calibrator Pack