FDA.reportPublic FDA data

Anti-RSV IFA (IgG)

Primary DI
04049016059240
Brand
Anti-RSV IFA (IgG)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
FI 2670-1010 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
LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKTRespiratory Syncytial Virus, Antigen, Antibody, IfaMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016059240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016059240040490160592404049016059240

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to respiratory syncytial virus (RSV) in a clinical specimen, using a fluorescent immunoassay 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
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
04053252282393Light Diagnostics ™ Respiratory Syncytial Virus (RSV) Control SlidesEMD Millipore CorporationLKT2022-12-01
04053252332555Light Diagnostics ™ SimulFluor® RSV/Para 3 ReagentEMD Millipore CorporationLKT2022-11-30
04053252472978Light Diagnostics ™ RSV FITC-Labeled Monoclonal AntibodyEMD Millipore CorporationLKT2022-11-30
04053252783234Light Diagnostics ™ Respiratory syncytial Virus (RSV) Control SlideEMD Millipore CorporationLKT2022-11-30
04053252589591Light Diagnostics ™ RSV Monoclonal Antibody EMD Millipore CorporationLKT2022-11-29
04053252732294Light Diagnostics™ SimulFluor® RSV/Para 3 DFA KitEMD Millipore CorporationLKT2022-11-28
08436037124624Light Diagnostics™ Respiratory Syncytial Virus DFA KitEMD Millipore CorporationLKT2022-11-28
05056080501680PathoDX Respiratory Viral PanelREMEL EUROPE LIMITEDLKT2021-07-21
05056080501697PathoDX Influenza A ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501703PathoDX Influenza B ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501710PathoDX Adenovirus ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501727PathoDx Parainfluenza 1 ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501734PathoDx Parainfluenza 2 ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501741PathoDx Parainfluenza 3 ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501758PathoDX RSV ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501765PathoDX Respiratory Mounting FluidREMEL EUROPE LIMITEDLKT2021-07-21
05056080501772PathoDX RVP Control SlidesREMEL EUROPE LIMITEDLKT2021-07-21
05056080501789PathoDX RSV Direct SpecimenREMEL EUROPE LIMITEDLKT2021-07-21
05056080501796 PathoDX RSV Control SlidesREMEL EUROPE LIMITEDLKT2021-07-21
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30014613330905D3 DuetDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330912D3 DuetDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330929D3 DuetDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330769D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2018-07-22
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