D-10 Dual 2200128

GUDID 00847817003394

D-10 Dual Program HbA1c Calibrator/Diluent Set

BIO-RAD LABORATORIES, INC.

Glycated haemoglobin (HbA1c) IVD, calibrator

• Primary Device ID: 00847817003394
• NIH Device Record Key: 048fc194-72ca-4e03-9ff7-57d0d49a097e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-10 Dual
• Version Model Number: 220-0128
• Catalog Number: 2200128
• 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
• 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 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847817003394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041444

FDA Product Code

• JIT: CALIBRATOR, SECONDARY

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 Dual]

• 00847817003509: D-10 Dual Program HbA2/F/A1c Calibrator/Diluent Set
• 00847817003455: D-10 Dual Program Elution Buffer 2
• 00847817003448: D-10 Dual Program Elution Buffer 1
• 00847817003394: D-10 Dual Program HbA1c Calibrator/Diluent Set
• 00847817000096: D-10 Dual Program Reorder Pack