D-10 2200149

GUDID 00847817003417

D-10 Sample Vials

BIO-RAD LABORATORIES, INC.

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