VIROTROL 00102B

GUDID 00847661005773

VIROTROL I (An unassayed (human) serological control.)

BIO-RAD LABORATORIES, INC.

Multiple blood-borne virus antigen/antibody IVD, control
Primary Device ID00847661005773
NIH Device Record Key736c74a9-624c-4b94-b067-46ae5b0a77c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIROTROL
Version Model Number00102B
Catalog Number00102B
Company DUNS051624070
Company NameBIO-RAD LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)854-6737
Emailqsd.techservice@bio-rad.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847661005773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSFKIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-23
Device Publish Date2016-09-12

On-Brand Devices [VIROTROL]

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

Trademark Results [VIROTROL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VIROTROL
VIROTROL
74202168 1700066 Live/Registered
Blackhawk Biosystems, Inc.
1991-09-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.