FDA.reportPublic FDA data

SeraQuest

Primary DI
00850487007418
Brand
SeraQuest
Company
QUEST INTERNATIONAL, INC.
Model
EB VCA M
Catalog number
Q01-480
Device description
Epstein-Barr virus (EBV) VCA immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850487007418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850487007418008504870074188504870074180850487007418

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
883350811
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850487007302ReQuest ANA ScreenQ01-310H2016-08-31
00850487007425SeraQuest ANA ScreenQ01-310H2016-08-31
00850487007234ReQuest Anti-TPO2016-08-31
00850487007500SeraQuest Anti-TPO2016-08-31
00850487007173ReQuest EB VCA MQ01-4802016-08-31
00850487007180ReQuestEB VCA GQ01-4702016-08-31
00850487007371SeraQuest EB VCA GQ01-4702016-08-31
00850487007005ReQuest Anti-SSAQ01-2502016-08-31
00850487007012ReQuestVZV GQ01-1802016-08-31
00850487007029ReQuest TOXO MQ01-1302016-08-31
00850487007036ReQuest TOXO GQ01-1202016-08-31
00850487007043ReQuest Syphilis GQ01-5802016-08-31
00850487007050ReQuest Sm/RNPQ01-2402016-08-31
00850487007067ReQuest RUB MQ01-1102016-08-31
00850487007074ReQuest RUB GQ01-1002016-08-31
00850487007081ReQuest Mumps MQ01-200M2016-08-31
00850487007098ReQuest MUMPS GQ01-2002016-08-31
00850487007104ReQuest MEAS MQ01-190M2016-08-31
00850487007111ReQuestMEAS GQ01-1902016-08-31
00850487007128ReQuest HSV Type 2 GQ01-4202016-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00847865010801Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LJN2023-01-04
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
00816057020652ASI EB VCA IgM EIA TestARLINGTON SCIENTIFIC, INC.LJN2016-07-08