FDA.reportPublic FDA data

Anti-HSV-2 (gG2) ELISA (IgG)

Primary DI
04049016096733
Brand
Anti-HSV-2 (gG2) ELISA (IgG)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
EI 2532-9601-24 G
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K061239000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061239000EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KITEuroimmun Us, LLC2007-06-28MYF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016096733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016096733040490160967334049016096733

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
322209263
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
04049016158547Anti-Measles Virus ELISA 2.0 (IgG)EI 2610-9601-2 G2026-05-29
04049016152071TITERPLANE set for the incubation of slides with 10 fieldsZZ 9999-0101-18-R2026-05-11
04049016152118Coded reagent tray for slides with 10 fieldsZZ 9999-0110-12-R2026-05-11
04049016152132Coded reagent tray for slides with 50 fieldsZZ 9999-0150-13-R2026-05-11
04049016152156Coded glass plates for the incubation of slides with 10 fieldsZZ 9999-0510-15-R2026-05-11
04049016152163Coded glass plates for the incubation of slides with 50 fieldsZZ 9999-0550-16-R2026-05-11
04049016155638Incubation tray 44 channels, blackZD 9892-30442026-05-11
04049016151302FITC-labelled anti-human IgA with Evans BlueAF 601-0540-R2026-03-04
04049016151319FITC-labelled anti-human IgG with Evans BlueAF 602-0540-R2026-02-10
04049016151647FITC-labelled anti-human IgG with Evans BlueAF 602-0546-R2026-02-10
04049016026976ANA Screen ELISA (IgG)EA 1590-9601-8 G2016-09-24
04049016045335ANA IFA: HEp-20-10FA 1522-10032016-09-24
04049016045342ANA IFA: HEp-20-10FA 1522-10052016-09-24
04049016045359ANA IFA: HEp-20-10FA 1522-10102016-09-24
04049016045366ANA IFA: HEp-20-10FA 1522-10502016-09-24
04049016045380ANA IFA: HEp-20-10FA 1522-20032016-09-24
04049016045397ANA IFA: HEp-20-10FA 1522-20052016-09-24
04049016045403ANA IFA: HEp-20-10FA 1522-20102016-09-24
04049016099017IFA 40: HEp-20-10FA 1522-1010-12016-09-24
04049016099024IFA 40: HEp-20-10FA 1522-2005-12016-09-24

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
03610522051236Bio-RadBio-RAD Laboratories, Inc.MYF2019-05-28
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
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