FDA.reportPublic FDA data

Anti-RSV ELISA (IgM)

Primary DI
04049016028246
Brand
Anti-RSV ELISA (IgM)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
EI 2670-9601 M
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
MCERespiratory Syncytial Virus - Elisa

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCERespiratory Syncytial Virus - ElisaMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016028246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016028246040490160282464049016028246

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory syncytial virus (RSV) 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 respiratory syncytial virus (RSV) 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
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04049016099031IFA 40: HEp-20-10FA 1522-2010-12016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ENTIRSVG03800NovaLisa Respiratory Syncytial Virus IgGGold Standard Diagnostics Frankfurt GmbHMCE2024-08-26
ENTIRSVG0380NovaLisa Respiratory Syncytial Virus IgGGold Standard Diagnostics Frankfurt GmbHMCE2024-08-26
04048474035070RSV IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMCE2023-08-29
00840239035073RSV IgG ELISA DRG International IncMCE2023-08-24
00404847435078RSV IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMCE2021-06-07
30014613201939QuickVueQUIDEL CORPORATIONMCE2018-11-10
04049016028222Anti-RSV ELISA (IgA)EUROIMMUN Medizinische Labordiagnostika AGMCE2016-09-24
04049016028239Anti-RSV ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMCE2016-09-24