D-10 12010405

GUDID 03610522126750

D-10 Hemoglobin Testing System

BIO-RAD LABORATORIES, INC.

Glycated haemoglobin (HbA1C) analyser IVD Glycated haemoglobin (HbA1C) analyser IVD Glycated haemoglobin (HbA1C) analyser IVD Glycated haemoglobin (HbA1C) analyser IVD Glycated haemoglobin (HbA1C) analyser IVD Glycated haemoglobin (HbA1C) analyser IVD Glycated haemoglobin (HbA1C) analyser IVD Glycated haemoglobin (HbA1C) analyser IVD Glycated haemoglobin (HbA1C) analyser IVD Glycated haemoglobin (HbA1C) analyser IVD Glycated haemoglobin (HbA1C) analyser IVD Glycated haemoglobin (HbA1C) analyser IVD Glycated haemoglobin (HbA1C) analyser IVD Glycated haemoglobin (HbA1C) analyser IVD Glycated haemoglobin (HbA1C) analyser IVD Glycated haemoglobin (HbA1C) analyser IVD

• Primary Device ID: 03610522126750
• NIH Device Record Key: 52a6bb4f-598c-47bf-9ae9-1ed080d41a28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-10
• Version Model Number: 12010405
• Catalog Number: 12010405
• Company DUNS: 132528295
• Company Name: BIO-RAD LABORATORIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	03610522126750 [Primary]

FDA Product Code

• LDM: INSTRUMENTATION, HIGH PRESSURE LIQUID CHROMATOGRAPHY

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [D-10]

• 00847817003462: D-10 Analytical Cartridge Hemoglobin A1c Program or Hemoglobin A2/F/A1c Program
• 00847817003417: D-10 Sample Vials
• 00847817003356: D-10 Hemoglobin A1c Program Calibrator/Diluent Set
• 00847817003318: D-10 Analytical Cartridge Hemoglobin A1c Program
• 00847817003301: D-10 Wash/Diluent Solution
• 00847817003295: D-10 Hemoglobin A1c Program Elution Buffer 2
• 00847817003288: D-10 Hemoglobin A1c Program Elution Buffer 1
• 00847817003271: D-10 Hemoglobin A1c Supplemental Reagent Pack
• 00847817000089: D-10 Hemoglobin A1c Program REORDER PACK
• 03610521164319: D-10 Hemoglobin A1c Program Calibrator/Diluent Set
• 03610521164302: D-10 Hemoglobin A1c Program Analytical Cartridge
• 03610520530108: D-10 Hemoglobin A1c Program
• 03610522126750: D-10 Hemoglobin Testing System