D-10 Dual 2200218

GUDID 00847817003509

D-10 Dual Program HbA2/F/A1c Calibrator/Diluent Set

BIO-RAD LABORATORIES, INC.

Haemoglobin A2 (HbA2) IVD, calibrator Haemoglobin A2 (HbA2) IVD, calibrator Haemoglobin A2 (HbA2) IVD, calibrator Haemoglobin A2 (HbA2) IVD, calibrator Haemoglobin A2 (HbA2) IVD, calibrator Haemoglobin A2 (HbA2) IVD, calibrator Haemoglobin A2 (HbA2) IVD, calibrator Haemoglobin A2 (HbA2) IVD, calibrator

• Primary Device ID: 00847817003509
• NIH Device Record Key: 4da5d8d5-a3d2-4864-b7d2-963d5609c656
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-10 Dual
• Version Model Number: 220-0218
• Catalog Number: 2200218
• 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	00847817003509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041444

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 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