VIROTROL 00108B

GUDID 00847661005582

VIROTROL HIV-1 Ag (An unassayed (human) serological control.)

BIO-RAD LABORATORIES, INC.

HIV1 antigen IVD, control

• Primary Device ID: 00847661005582
• NIH Device Record Key: 9faa201c-ef11-4a24-989f-568453039d9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIROTROL
• Version Model Number: 00108B
• Catalog Number: 00108B
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847661005582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK930033

FDA Product Code

• KSF: KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS

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 [VIROTROL]

• 00847661005780: VIROTROL I (An unassayed (human) serological control.)
• 00847661005773: VIROTROL I (An unassayed (human) serological control.)
• 00847661005629: VIROTROL II (An unassayed (human) serological control.)
• 00847661005612: VIROTROL HIV-2 (An unassayed (human) serological control.)
• 00847661005605: VIROTROL HIV-2 (An unassayed (human) serological control.)
• 00847661005599: VIROTROL HIV-2 (An unassayed (human) serological control.)
• 00847661005582: VIROTROL HIV-1 Ag (An unassayed (human) serological control.)
• 00847661005551: VIROTROL I (An unassayed (human) serological control.)
• 00847661005544: VIROTROL I (An unassayed (human) serological control.)
• 00847661005537: VIROTROL I (An unassayed (human) serological control.)
• 00847661005520: VIROTROL I (An unassayed (human) serological control.)
• 00847661005513: VIROTROL I (An unassayed (human) serological control.)
• 00847661005506: VIROTROL II (An unassayed (human) serological control.)
• 00847661005490: VIROTROL II (An unassayed (human) serological control.)
• 00847661005421: VIROTROL II (An unassayed (human) serological control.)
• 00847661005322: VIROTROL I (An unassayed (human) serological control.)
• 00847661004998: VIROTROL HIV-1 Ag (An unassayed (human) serological control.)
• 00847661004776: VIROTROL I (An unassayed (human) serological control.)
• 00847661004769: VIROTROL I (An unassayed (human) serological control.)
• 00847661004752: VIROTROL I (An unassayed (human) serological control.)
• 00847661004745: VIROTROL I (An unassayed (human) serological control.)
• 00847661004738: VIROTROL I (An unassayed (human) serological control.)
• 00847661004707: VIROTROL I (An unassayed (human) serological control.)
• 00847661004684: VIROTROL III (An unassayed (human) serological control.)
• 00847661004585: VIROTROL III (An unassayed (human) serological control.)
• 00847661004240: VIROTROL I (An unassayed (human) serological control.)
• 03610522207893: VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
• 03610522207886: VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
• 03610522207879: VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
• 03610522207862: VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
• 03610522207855: VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
• 03610522207848: VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
• 03610520540718: VIROTROL ToRCH-M (An unassayed (human) serology control.)
• 03610520530146: VIROTROL PLUS-R (An unassayed (human) serology control)
• 03610520105900: VIROTROL HIV-1 gO (An unassayed (human) serology control.)
• 03610520105719: VIROTROL HIV-1 gO (An unassayed (human) serology control.)
• 00847661005704: VIROTROL HAV-IgM (An unassayed (human) serology control.)
• 00847661005575: VIROTROL EBV (An unassayed (human) serology control.)
• 00847661005568: VIROTROL EBV (An unassayed (human) serology control.)
• 00847661005476: VIROTROL ToRCH-M (An unassayed (human) serology control.)
• 00847661005469: VIROTROL Syphilis LR-A (An unassayed (human) serology control.)
• 00847661005452: VIROTROL Syphilis LR-B (An unassayed (human) serology control.)
• 00847661005445: VIROTROL ToRCH Q (An unassayed (human) serology control.)
• 00847661005438: VIROTROL Syphilis LR-A (An unassayed (human) serology control.)
• 00847661005315: VIROTROL Syphilis LR-B (An unassayed (human) serology control.)
• 00847661002932: VIROTROL Chagas (An unassayed (human) serology control.)
• 00847661002925: VIROTROL Chagas (An unassayed (human) serology control.)
• 00847661002918: VIROTROL RPR Panel (An unassayed (human) serology control.)
• 00847661002857: VIROTROL HBeAg (An unassayed (human) serology control.)
• 00847661002840: VIROTROL HBc-IgM (An unassayed (human) serology control.)