FDA.reportPublic FDA data

biokitHSV-2

Primary DI
08426951056439
Brand
biokitHSV-2
Company
BIOKIT, S.A.
Model
300028001
Device description
20 Test Devices20 x 0,7 ml Sample Diluent20 x 0,5 ml Developing Reagent20 x Empty Vials 120 x Pre-filter tips20 x Capillary tubes20 x Lancets20 x Swabs20 x Tube racks
Published
2022-10-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983886000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983886000POCKIT HSV 2 RAPID TESTDiagnology , Ltd.1999-08-19LGC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426951056439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426951056439084269510564398426951056439

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of immunoglobulin G (IgG) antibodies to herpes simplex virus 2 (HSV2) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-926-3353support@inovadx.com

Regulatory Flags#

DUNS number
460055742
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08426950639725BIO-FLASH3710-03442016-09-23
08426950344773Color Mono 50 TESTS3000-10052016-09-23
08426950590453ASO Titer Control3000210602016-09-23
08426950590477RF Titer Control3000210622016-09-23
08426950590569Rubagen 100 TESTS3000240012016-09-23
08426950590576Rubajet 100 TESTS3000240112016-09-23
08426950590583Rubajet 500 TESTS3000240122016-09-23
08426950589365Rheumajet CRP 100 TESTS3000-70512016-09-23
08426950590460CRP Titer Control3000210612016-09-23
08426950001676Monogen 50 TESTS3000-10012016-09-23
08426950585350Monogen 150 TESTS3000-10022016-09-23
08426950589334Rheumajet RF 100 TESTS3000-70332016-09-23
08426950590613Rheumajet RF 50 TESTS3000270342016-09-23
08426950592327Biokit RPR 500 TESTS3006255502016-09-23
08426950457305Rheumajet ASO 100 TESTS3000-70102016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026644QMedix™Diagnostic Automation, Inc.LGC2024-06-25
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
00850487007142ReQuestQUEST INTERNATIONAL, INC.LGC2016-08-31
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