FDA.reportPublic FDA data

ReQuest

Primary DI
00850487007142
Brand
ReQuest
Company
QUEST INTERNATIONAL, INC.
Model
HSV G
Catalog number
Q01-160
Device description
Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) 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
LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-SpecificMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850487007142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850487007142008504870071428504870071420850487007142

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
00850054026644QMedix™Diagnostic Automation, Inc.LGC2024-06-25
08426951056439biokitHSV-2BIOKIT, S.A.LGC2022-10-10
00894175000046AccuDiag ™ Diagnostic Automation, Inc.LGC2021-08-10
B3507203400Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test KitGold Standard Diagnostics CorporationLGC2020-08-28
B3507203500Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test KitGold Standard Diagnostics CorporationLGC2020-06-03
00630414016726ADVIA Centaur Herpes-2 IgGSiemens Healthcare Diagnostics Inc.LGC2019-04-09
00630414964171IMMULITE® / IMMULITE® 1000 Systems HER Herpes I and II IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLGC2016-09-24
00630414999784IMMULITE® 2000 Systems Herpes I and II IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLGC2016-09-24
05391516743709Trinity BiotechCLARK LABORATORIES, INC.LGC2016-09-23
05391516746489Trinity BiotechCLARK LABORATORIES, INC.LGC2016-09-23
10816101021014HSV-1 AND HSV-2 Differentiation Immunoblot IgG Antigen StripsDIASORIN MOLECULAR LLCLGC2016-09-22
10816101021021HSV-1 and HSV-2 Immunoblot IgG Cutoff/Positive ControlDIASORIN MOLECULAR LLCLGC2016-09-22
10816101021038HSV-1 and HSV-2 Immunoblot IgG Negative ControlDIASORIN MOLECULAR LLCLGC2016-09-22
20816101021004HerpeSelect® 1 and 2 Immunoblot IgGDIASORIN MOLECULAR LLCLGC2016-09-22
00817273020174DiamedixDIAMEDIX CORPORATIONLGC2016-09-20
05391516746496Trinity BiotechCLARK LABORATORIES, INC.LGC2016-09-19
00847865010740Bio-Rad Laboratories, Inc.Bio-RAD Laboratories, Inc.LGC2016-09-12
00850487007333SeraQuestQUEST INTERNATIONAL, INC.LGC2016-08-31
00811727015211Pointe Scientific, Inc. HSV-1 & 2 IgGHORIBA INSTRUMENTS INCORPORATEDLGC2016-08-31
00816057020577ASI HSV IgG EIA TestARLINGTON SCIENTIFIC, INC.LGC2016-07-08