FDA.reportPublic FDA data

Bio-Rad Laboratories

Primary DI
00847865010801
Brand
Bio-Rad Laboratories
Company
Bio-RAD Laboratories, Inc.
Model
25185
Catalog number
25185
Device description
EB VCA IgM EIA
Published
2023-01-04
Public version status
New
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
LJNANTIBODY IGM, IF, EPSTEIN-BARR VIRUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJNAntibody Igm, If, Epstein-Barr VirusMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033780000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033780000MODIFICATION TO SERAQUEST VCA IGMQuest Intl., Inc.2004-01-15LJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847865010801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865010801008478650108018478650108010847865010801

GMDN Terms#

Term, Definition table
TermDefinition
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Epstein-Barr virus (EBV) in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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)224-6723techsupport.ussd-redmond@bio-rad.com

Regulatory Flags#

DUNS number
844766394
Device count
1
Kit
true
Lot or batch
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
B110EB50120Epstein-Barr Virus (VCA) Antigen Substrate, 12 wells, For IFA Test SystemBion Enterprises, Ltd.LJN2016-09-12
B110EBG50200EBV IgG ControlBion Enterprises, Ltd.LJN2016-09-12
B110EBM1200EBV-VCA IgM Test System, 120 TestsBion Enterprises, Ltd.LJN2016-09-12
B110EBM50300EBV IgM ControlBion Enterprises, Ltd.LJN2016-09-12
B110EBN50100EBV Negative ControlBion Enterprises, Ltd.LJN2016-09-12
00847865000291BioPlex 2200BIO-RAD LABORATORIES, INC.LJN2016-09-12
00847865001236BioPlex 2200BIO-RAD LABORATORIES, INC.LJN2016-09-12
00847865002455BioPlex 2200BIO-RAD LABORATORIES, INC.LJN2016-09-12
00847865011341BioPlex 2200BIO-RAD LABORATORIES, INC.LJN2016-09-12
00847865011358BioPlex 2200BIO-RAD LABORATORIES, INC.LJN2016-09-12
00850487007173ReQuest QUEST INTERNATIONAL, INC.LJN2016-08-31
00850487007418SeraQuestQUEST INTERNATIONAL, INC.LJN2016-08-31
00816057020652ASI EB VCA IgM EIA TestARLINGTON SCIENTIFIC, INC.LJN2016-07-08