VIROCLEAR 00107

GUDID 00847661002581

VIROCLEAR (An unassayed (human) serological control.)

BIO-RAD LABORATORIES, INC.

Multiple blood-borne virus antigen/antibody IVD, control

• Primary Device ID: 00847661002581
• NIH Device Record Key: 48492018-65ab-4774-9ad7-0014496ebe18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIROCLEAR
• Version Model Number: 00107
• Catalog Number: 00107
• Company DUNS: 051624070
• 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: false
• 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)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@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	00847661002581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK000041

FDA Product Code

• MYZ: Kit,test(donors),for bloodborne pathogen

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 [VIROCLEAR]

• 00847661002581: VIROCLEAR (An unassayed (human) serological control.)
• 00847661002574: VIROCLEAR (An unassayed (human) serological control.)
• 00847661002567: VIROCLEAR (An unassayed (human) serological control.)
• 03610522207930: VIROCLEAR SARS-CoV-2 (An unassayed (human) serology control.)
• 03610522207923: VIROCLEAR SARS-CoV-2 (An unassayed (human) serology control.)
• 00847661002727: VIROCLEAR EBV (An unassayed (human) serology control.)
• 00847661002642: VIROCLEAR ToRCH (An unassayed (human) serology control.)