FDA.reportPublic FDA data

VIROTROL

Primary DI
00847661004684
Brand
VIROTROL
Company
BIO-RAD LABORATORIES, INC.
Model
00110A
Catalog number
00110A
Device description
VIROTROL III (An unassayed (human) serological control.)
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSFKIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSFKit, Quality Control For Blood Banking ReagentsHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK930034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK930034000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847661004684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847661004684008476610046848476610046840847661004684

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood-borne virus antigen/antibody IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of antigens and/or antibodies from one or multiple blood-borne viruses, in a clinical specimen. Viruses intended to be detected may include (but are not limited to) human immunodeficiency virus 1 and 2 (HIV1 and HIV2), Hepatitis B virus, Hepatitis C virus and human T-cell lymphotrophic virus 1 and/or 2 (HTLV1 and/or HTLV2).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-6737qsd.techservice@bio-rad.com

Regulatory Flags#

DUNS number
051624070
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847661000778Lyphochek7447442016-09-12
00847661000785Lyphochek7457452016-09-12
00847661000792Lyphochek7467462016-09-12
00847661001027Lyphochek5975972016-09-12
00847661001034Lyphochek5985982016-09-12
00847661001041Lyphochek5995992016-09-12
00847661001898Lyphochek598X598X2016-09-12
00847661001959Lyphochek745X745X2016-09-12
0361052031061896AN96AN-BPU-QUEST96AN-BPU-QUEST2016-09-12
03610520547663ANA PLATE196AN-BPU196AN-BPU2016-09-12
0361052056045796AN96AN-BPU-TRINITY96AN-BPU-TRINITY2016-09-12
03610520569184ANA PLATE196AN-BPU-ED196AN-BPU-ED2016-09-12
00847661000082Liquichek1071072016-09-12
00847661000099Liquichek1081082016-09-12
00847661000105Liquichek1111112016-09-12
00847661000112Liquichek1121122016-09-12
00847661000129Liquichek1181182016-09-12
00847661000204Liquichek1291292016-09-12
00847661000211Liquichek1311312016-09-19
00847661000228Liquichek1301302016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060242473067Ortho™ Confidence Manual SystemALBA BIOSCIENCE LIMITEDKSF2026-03-12
M220762002Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KSF2025-09-11
M220762003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KSF2025-09-11
04065266566086ORTHO Daily QC Simulated Whole Blood Quality Control KitMILLIPORE (U.K.) LIMITEDKSF2024-04-10
10888234002307Capture-R Ready Indicator Red CellsIMMUCOR, INC.KSF2022-09-03
05060242472473ALBAcheck - BGS Monoclonal ControlALBA BIOSCIENCE LIMITEDKSF2020-06-19
05060242472459ALBAcheck - BGS Monoclonal ControlALBA BIOSCIENCE LIMITEDKSF2020-06-19
05060242472329ALBAcyte IgG Sensitized Red Blood Cells IIALBA BIOSCIENCE LIMITEDKSF2019-05-10
05060242472336ALBAcyte IgG Sensitized Red Blood Cells IIALBA BIOSCIENCE LIMITEDKSF2019-05-10
23661562105438Neg ControlDIAGASTKSF2018-05-01
07611969952342IH-Internal QCBio-Rad Medical Diagnostics GmbHKSF2018-04-05
07611969952335IH-Basic QCBio-Rad Medical Diagnostics GmbHKSF2018-02-28
00816784020871ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2017-12-01
00816784020888ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2017-12-01
00858352006122MQCHEMO BIOSCIENCE INCKSF2017-06-28
00858352006139MQC-CATHEMO BIOSCIENCE INCKSF2017-06-26
05060242470943AlbaQ-Chek® ALBA BIOSCIENCE LIMITEDKSF2017-03-29
00816784020772ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2017-03-09
07611969952212IH-Card ControlBio-Rad Medical Diagnostics GmbHKSF2017-01-20
00858352006009Hemo-QCHEMO BIOSCIENCE INCKSF2016-10-20
00858352006016C3 Control CellsHEMO BIOSCIENCE INCKSF2016-09-29
00816784020437ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-27
05060242471162ALBAcyte IgG Sensitized Red Blood CellsALBA BIOSCIENCE LIMITEDKSF2016-09-24
00816784020024ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020031ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020048ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020055ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020062ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020123ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020215ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24