D-10 2200149

GUDID 00847817003417

D-10 Sample Vials

BIO-RAD LABORATORIES, INC.

Haemoglobin A2 (HbA2) IVD, reagent Haemoglobin A2 (HbA2) IVD, reagent Haemoglobin A2 (HbA2) IVD, reagent Haemoglobin A2 (HbA2) IVD, reagent Haemoglobin A2 (HbA2) IVD, reagent Haemoglobin A2 (HbA2) IVD, reagent Haemoglobin A2 (HbA2) IVD, reagent Haemoglobin A2 (HbA2) IVD, reagent

• Primary Device ID: 00847817003417
• NIH Device Record Key: 1221063d-fc1f-4907-b009-65a55e7dc886
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-10
• Version Model Number: 220-0149
• Catalog Number: 2200149
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

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	00847817003417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031043

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: 6
• Public Version Date: 2020-01-23
• Device Publish Date: 2016-09-12

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