FDA.reportPublic FDA data

SeraQuest

Primary DI
00850487007548
Brand
SeraQuest
Company
QUEST INTERNATIONAL, INC.
Model
HSV Type 1 G
Catalog number
01-410
Device description
Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Published
2016-11-30
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
MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850487007548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850487007548008504870075488504870075480850487007548

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) 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 G (IgG) antibodies to herpes simplex virus 1 (HSV1) in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
00850487007418SeraQuest EB VCA MQ01-4802016-08-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870024332HSV 1+2 IgG AccuLite® CLIA Test System (6775-300A, 6775-300B)MONOBIND, INC.MXJ2024-09-13
00816870024363HSV 1+2 IgM AccuBind® ELISA Test System (6825-300A, 6825-300B)MONOBIND, INC.MXJ2024-09-13
00816870024370HSV 1+2 IgM AccuLite® CLIA Test System (6875-300A, 6875-300B)MONOBIND, INC.MXJ2024-09-13
00380740197704AlinityAbbott Ireland DiagnosticsMXJ2024-05-14
00380740213879AlinityAbbott Ireland DiagnosticsMXJ2024-05-14
00380740213886AlinityAbbott Ireland DiagnosticsMXJ2024-05-14
00850054026095AccuDiag ™Diagnostic Automation, Inc.MXJ2023-06-27
07613336170656Elecsys HSV-1 IgGRoche Diagnostics GmbHMXJ2022-12-06
07613336170663Elecsys HSV-1 IgGRoche Diagnostics GmbHMXJ2022-12-06
00842768022784Atellica IM Herpes-1 IgGSiemens Healthcare Diagnostics Inc.MXJ2022-10-28
03610522051076Bio-RadBio-RAD Laboratories, Inc.MXJ2019-05-28
00630414016740ADVIA Centaur Herpes-1 IgGSiemens Healthcare Diagnostics Inc.MXJ2019-04-09
10816101022356DxSelect™ - 10X Wash BufferDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022363HSV-1 IgG Antigen WellsDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022387HerpeSelect ELISA Sample DiluentDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022301DxSelect™ - Stop ReagentDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022295DxSelect™ - Substrate ReagentDIASORIN MOLECULAR LLCMXJ2017-07-11
04015630940431Elecsys HSV-1 IgGRoche Diagnostics GmbHMXJ2017-04-21
00850487007135ReQuestQUEST INTERNATIONAL, INC.MXJ2016-11-30
08056771600231LIAISON® HSV-1 Type Specific IgGDiasorin Inc.MXJ2016-09-24
08056771600248LIAISON® Control HSV-1 IgGDiasorin Inc.MXJ2016-09-24
04049016096726Anti-HSV-1 (gC1) ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMXJ2016-09-24
05391516743471Trinity BiotechCLARK LABORATORIES, INC.MXJ2016-09-23
05391516743488Trinity BiotechCLARK LABORATORIES, INC.MXJ2016-09-23
05391516747035Trinity BiotechCLARK LABORATORIES, INC.MXJ2016-09-23
10816101022073HSV-1 ELISA IgG Cutoff CalibratorDIASORIN MOLECULAR LLCMXJ2016-09-22
10816101022080HSV ELISA Negative ControlDIASORIN MOLECULAR LLCMXJ2016-09-22
10816101022097HSV-1 ELISA IgG High Positive ControlDIASORIN MOLECULAR LLCMXJ2016-09-22
10816101022103HSV-1 ELISA IgG Low Positive ControlDIASORIN MOLECULAR LLCMXJ2016-09-22
10816101022165HSV-1 ELISA IgG ConjugateDIASORIN MOLECULAR LLCMXJ2016-09-22