FDA.reportPublic FDA data

VIROCLEAR

Primary DI
00847661002567
Brand
VIROCLEAR
Company
BIO-RAD LABORATORIES, INC.
Model
00106
Catalog number
00106
Device description
VIROCLEAR (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
MYZKit,test(donors),for bloodborne pathogen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYZKit, Test (Donors), For Bloodborne PathogenUnknown2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK000041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK000041000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847661002567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847661002567008476610025678476610025670847661002567

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
00816784020901ACCURUN® 365 Series 200 Lgc Clinical Diagnostics, Inc.MYZ2020-08-24
00816784020253ACCURUN®Lgc Clinical Diagnostics, Inc.MYZ2018-09-24
00816784020260ACCURUN®Lgc Clinical Diagnostics, Inc.MYZ2018-09-24
00884883006270Acrometrix WNVRNAMicrogenics CorporationMYZ2018-09-17
00884883005907AcroMetrix BB NAT WNV Negative ControlMicrogenics CorporationMYZ2017-01-25
00884883005891Acrometrix BB NAT HIV-1 POS. CTRLMicrogenics CorporationMYZ2016-09-22
00884883005921AcroMetrix BB NAT HCV Positive ControlMicrogenics CorporationMYZ2016-09-22
00884883005945AcroMetrix BB NAT Negative ControlMicrogenics CorporationMYZ2016-09-22
00847661002574VIROCLEARBIO-RAD LABORATORIES, INC.MYZ2016-09-12
00847661002581VIROCLEARBIO-RAD LABORATORIES, INC.MYZ2016-09-12