FDA.reportPublic FDA data

Bio-Rad Laboratories, Inc.

Primary DI
00847865010740
Brand
Bio-Rad Laboratories, Inc.
Company
Bio-RAD Laboratories, Inc.
Model
25179
Catalog number
25179
Device description
HSV IgG EIA
Published
2016-09-12
Public version status
Update
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
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
K963282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963282000SERAQUEST HSV IGGQuest Intl., Inc.1997-01-22LGC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847865010740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865010740008478650107408478650107400847865010740

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 1 & 2 (HSV1 & 2) 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 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
Expiration date on label
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
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
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