FDA.reportPublic FDA data

Anti-West Nile Virus ELISA (IgM)

Primary DI
04049016028185
Brand
Anti-West Nile Virus ELISA (IgM)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
EI 2662-9601 M
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NOPElisa, Antibody, West Nile Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOPElisa, Antibody, West Nile VirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153308000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153308000EUROIMMUN Anti-West Nile Virus ELISA (IgM)Euroimmun Us, Inc.2016-08-12NOP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016028185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016028185040490160281854049016028185

GMDN Terms#

Term, Definition table
TermDefinition
West Nile virus immunoglobulin M (IgM) 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 M (IgM) antibodies to West Nile virus 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
10816101022325West Nile Virus IgG DxSelect™ IgG Cutoff CalibratorDIASORIN MOLECULAR LLCNOP2017-07-11
10816101022332West Nile Virus IgG Positive Control DxSelect™ - IgG Positive ControlDIASORIN MOLECULAR LLCNOP2017-07-11
10816101022349West Nile Virus IgG DxSelect™ - IgG Antigen WellsDIASORIN MOLECULAR LLCNOP2017-07-11
10816101022318West Nile Virus IgG DxSelect™ - IgG ConjugateDIASORIN MOLECULAR LLCNOP2017-07-11
10816101022271West Nile Virus IgM Capture DxSelect™ Anti-Flavivirus ConjugateDIASORIN MOLECULAR LLCNOP2017-05-16
10816101022288West Nile Virus IgM Capture DxSelect™ IgM Cutoff Calibrator (0.3 mL)DIASORIN MOLECULAR LLCNOP2017-05-16
B379WNMS11 West Nile Detect IgM Capture ELISAINBIOS INTERNATIONAL, INCNOP2016-11-21
04049016028178Anti-West Nile Virus ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGNOP2016-09-24
10816101022219IgM Capture WellsDIASORIN MOLECULAR LLCNOP2016-09-22
10816101022042West Nile Virus DxSelect™ Negative ControlDIASORIN MOLECULAR LLCNOP2016-09-22
10816101022059West Nile Virus IgM Capture DxSelect™ Positive ControlDIASORIN MOLECULAR LLCNOP2016-09-22
10816101022066West Nile Virus IgM Capture DxSelect™ AntigenDIASORIN MOLECULAR LLCNOP2016-09-22
20816101022001West Nile Virus IgG DxSelect™DIASORIN MOLECULAR LLCNOP2016-09-22
20816101022018West Nile Virus IgG DxSelect™DIASORIN MOLECULAR LLCNOP2016-09-22
20816101022025West Nile Virus IgM Capture DxSelect™DIASORIN MOLECULAR LLCNOP2016-09-22
20816101022032West Nile Virus IgM Capture DxSelect™DIASORIN MOLECULAR LLCNOP2016-09-22