FDA.reportPublic FDA data

Anti-HSV-1 (gC1) ELISA (IgG)

Primary DI
04049016096726
Brand
Anti-HSV-1 (gC1) ELISA (IgG)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
EI 2531-9601-24 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
MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1Microbiology2

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
04049016096726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016096726040490160967264049016096726

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 1 (HSV1) 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 (HSV1) 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
00816870024332HSV 1+2 IgG AccuLite® CLIA Test System (6775-300A, 6775-300B)MONOBIND, INC.MXJ2024-09-13
00816870024363HSV 1+2 IgM AccuBind® ELISA Test System (6825-300A, 6825-300B)MONOBIND, INC.MXJ2024-09-13
00816870024370HSV 1+2 IgM AccuLite® CLIA Test System (6875-300A, 6875-300B)MONOBIND, INC.MXJ2024-09-13
00380740197704AlinityAbbott Ireland DiagnosticsMXJ2024-05-14
00380740213879AlinityAbbott Ireland DiagnosticsMXJ2024-05-14
00380740213886AlinityAbbott Ireland DiagnosticsMXJ2024-05-14
00850054026095AccuDiag ™Diagnostic Automation, Inc.MXJ2023-06-27
07613336170656Elecsys HSV-1 IgGRoche Diagnostics GmbHMXJ2022-12-06
07613336170663Elecsys HSV-1 IgGRoche Diagnostics GmbHMXJ2022-12-06
00842768022784Atellica IM Herpes-1 IgGSiemens Healthcare Diagnostics Inc.MXJ2022-10-28
03610522051076Bio-RadBio-RAD Laboratories, Inc.MXJ2019-05-28
00630414016740ADVIA Centaur Herpes-1 IgGSiemens Healthcare Diagnostics Inc.MXJ2019-04-09
10816101022356DxSelect™ - 10X Wash BufferDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022363HSV-1 IgG Antigen WellsDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022387HerpeSelect ELISA Sample DiluentDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022301DxSelect™ - Stop ReagentDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022295DxSelect™ - Substrate ReagentDIASORIN MOLECULAR LLCMXJ2017-07-11
04015630940431Elecsys HSV-1 IgGRoche Diagnostics GmbHMXJ2017-04-21
00850487007135ReQuestQUEST INTERNATIONAL, INC.MXJ2016-11-30
00850487007548SeraQuestQUEST INTERNATIONAL, INC.MXJ2016-11-30
08056771600231LIAISON® HSV-1 Type Specific IgGDiasorin Inc.MXJ2016-09-24
08056771600248LIAISON® Control HSV-1 IgGDiasorin Inc.MXJ2016-09-24
05391516743471Trinity BiotechCLARK LABORATORIES, INC.MXJ2016-09-23
05391516743488Trinity BiotechCLARK LABORATORIES, INC.MXJ2016-09-23
05391516747035Trinity BiotechCLARK LABORATORIES, INC.MXJ2016-09-23
10816101022073HSV-1 ELISA IgG Cutoff CalibratorDIASORIN MOLECULAR LLCMXJ2016-09-22
10816101022080HSV ELISA Negative ControlDIASORIN MOLECULAR LLCMXJ2016-09-22
10816101022097HSV-1 ELISA IgG High Positive ControlDIASORIN MOLECULAR LLCMXJ2016-09-22
10816101022103HSV-1 ELISA IgG Low Positive ControlDIASORIN MOLECULAR LLCMXJ2016-09-22
10816101022165HSV-1 ELISA IgG ConjugateDIASORIN MOLECULAR LLCMXJ2016-09-22