Whole Blood Primer 2700352

GUDID 00847817010613

Whole Blood Primer

BIO-RAD LABORATORIES, INC.

Glycated haemoglobin (HbA1c) IVD, reagent

• Primary Device ID: 00847817010613
• NIH Device Record Key: a5ffc153-1f88-42b0-aa7f-bc71604d7f8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Whole Blood Primer
• Version Model Number: 270-0352
• Catalog Number: 2700352
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847817010613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040872

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: 4
• Public Version Date: 2020-01-23
• Device Publish Date: 2016-09-12

On-Brand Devices [Whole Blood Primer]

• 00847817010613: Whole Blood Primer
• 00847817010606: Whole Blood Primer
• 00847817003400: Whole Blood Primer