FDA.reportPublic FDA data

Bio-Rad

Primary DI
03610522051236
Brand
Bio-Rad
Company
Bio-RAD Laboratories, Inc.
Model
12008531
Catalog number
12008531
Device description
HSV Type 2 Specific IgG EIA Test Set
Published
2019-05-28
Public version status
Update
Distribution status
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
MYFEnzyme linked immunosorbent assay, herpes simplex virus, hsv-2

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152353000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152353000SeraQuest HSV Type 2 Specific IgGQuest International, Inc.2016-05-13MYF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03610522051236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610522051236036105220512363610522051236

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 2 (HSV2) 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 2 (HSV2) 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@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
00380740197742AlinityAbbott Ireland DiagnosticsMYF2025-10-14
00380740213893AlinityAbbott Ireland DiagnosticsMYF2025-10-14
00380740213909AlinityAbbott Ireland DiagnosticsMYF2025-10-14
00850054026088AccuDiag ™Diagnostic Automation, Inc.MYF2023-06-27
07613336170687Elecsys HSV-2 IgGRoche Diagnostics GmbHMYF2022-12-06
07613336170694Elecsys HSV-2 IgGRoche Diagnostics GmbHMYF2022-12-06
00842768022807Atellica IM Herpes-2 IgGSiemens Healthcare Diagnostics Inc.MYF2022-10-28
00630414016726ADVIA Centaur Herpes-2 IgGSiemens Healthcare Diagnostics Inc.MYF2019-04-09
10816101022370HSV-2 IgG Antigen WellsDIASORIN MOLECULAR LLCMYF2017-07-11
04015630940448Elecsys HSV-2 IgGRoche Diagnostics GmbHMYF2017-04-21
00850487007128ReQuest QUEST INTERNATIONAL, INC.MYF2016-10-31
08056771600101LIAISON® HSV-2 Type Specific IgGDiasorin Inc.MYF2016-09-24
04049016096733Anti-HSV-2 (gG2) ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMYF2016-09-24
05391516743501Trinity BiotechCLARK LABORATORIES, INC.MYF2016-09-23
05391516743518Trinity BiotechCLARK LABORATORIES, INC.MYF2016-09-23
05391516747059Trinity BiotechCLARK LABORATORIES, INC.MYF2016-09-23
10816101022110HSV-2 ELISA IgG Cutoff CalibratorDIASORIN MOLECULAR LLCMYF2016-09-22
10816101022127HSV-2 ELISA IgG High Positive ControlDIASORIN MOLECULAR LLCMYF2016-09-22
10816101022134HSV-2 ELISA IgG Low Positive ControlDIASORIN MOLECULAR LLCMYF2016-09-22
10816101022172HSV-2 ELISA IgG ConjugateDIASORIN MOLECULAR LLCMYF2016-09-22
20816101022186HerpeSelect® 2 ELISA IgGDIASORIN MOLECULAR LLCMYF2016-09-22
20816101022193HerpeSelect® 2 ELISA IgGDIASORIN MOLECULAR LLCMYF2016-09-22
05391516743327Trinity BiotechCLARK LABORATORIES, INC.MYF2016-09-21
05391516746939Trinity BiotechCLARK LABORATORIES, INC.MYF2016-09-21
04015630939053Elecsys HSV2 IgG ImmunoassayRoche Diagnostics GmbHMYF2016-09-20
00847865000949BioPlex 2200BIO-RAD LABORATORIES, INC.MYF2016-09-12
00847865002172BioPlex 2200BIO-RAD LABORATORIES, INC.MYF2016-09-12
00847865002479BioPlex 2200BIO-RAD LABORATORIES, INC.MYF2016-09-12
00847865004725BioPlex 2200BIO-RAD LABORATORIES, INC.MYF2016-09-12
00847865010993BioPlex 2200BIO-RAD LABORATORIES, INC.MYF2016-09-12