FDA.reportPublic FDA data

Anti-Parainfluenza Viruses Pool ELISA (IgA)

Primary DI
04049016028369
Brand
Anti-Parainfluenza Viruses Pool ELISA (IgA)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
EI 2721-9601-1 A
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
GQTAntisera, Cf, Parainfluenza Virus 1-4

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQTAntisera, Cf, Parainfluenza Virus 1-4Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016028369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016028369040490160283694049016028369

GMDN Terms#

Term, Definition table
TermDefinition
Multiple human parainfluenza virus immunoglobulin A (IgA) 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 A (IgA) antibodies to one or multiple strains of human parainfluenza 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
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
04053252325519Light Diagnostics ™ Parainfluenza 1, 2, 3 Control SlidesEMD Millipore CorporationGQT2022-12-01
04053252670114Light Diagnostics ™ Parainfluenza 4 Control Slides (5 Pack)EMD Millipore CorporationGQT2022-12-01
04053252280238Light Diagnostics ™ Parainfluenza 3 FITC-Labeled Monoclonal AntibodyEMD Millipore CorporationGQT2022-11-30
04053252362224Light Diagnostics ™ Parainfluenza 2 FITC-Labeled Monoclonal AntibodyEMD Millipore CorporationGQT2022-11-30
04053252403040Light Diagnostics ™ SimulFluor® Parainfluenza 1, 2/3 ReagentEMD Millipore CorporationGQT2022-11-30
04053252471469Light Diagnostics ™ Parainfluenza Pan FITC-Labeled Monoclonal AntibodiesEMD Millipore CorporationGQT2022-11-30
04053252728365Light Diagnostics ™ Para 4 DFA ReagentEMD Millipore CorporationGQT2022-11-30
04053252730818Light Diagnostics ™ Parainfluenza 1 FITC-Labeled Monoclonal AntibodyEMD Millipore CorporationGQT2022-11-30
04053252739583Light Diagnostics ™ SimulFluor® Para 1, 2, 3/ Adeno ReagentEMD Millipore CorporationGQT2022-11-30
04053252783258Light Diagnostics ™ Para-influenza 1, 2, 3 Control SlideEMD Millipore CorporationGQT2022-11-30
04061841171485Light Diagnostics ™ Para 4 Control SlideEMD Millipore CorporationGQT2022-11-30
04053252322273Light Diagnostics ™ Parainfluenza 2 Monoclonal AntibodyEMD Millipore CorporationGQT2022-11-29
04053252513121Light Diagnostics™ SimulFluor® Para 1, 2, 3/ Adeno DFA KitEMD Millipore CorporationGQT2022-11-29
04053252672743Light Diagnostics ™ Parainfluenza 1 Monoclonal AntibodyEMD Millipore CorporationGQT2022-11-29
04053252728358Light Diagnostics™ SimulFluor® Parainfluenza 1, 2 /3 DFA KitEMD Millipore CorporationGQT2022-11-29
04053252738081Light Diagnostics ™ Parainfluenza 2 Monoclonal AntibodyEMD Millipore CorporationGQT2022-11-29
08436037124891Light Diagnostics™ Parainfluenza 1, 2, and 3 DFA KitEMD Millipore CorporationGQT2022-11-28
04049016028376Anti-Parainfluenza Viruses Pool ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGQT2016-09-24
04049016028383Anti-Parainfluenza Viruses Pool ELISA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGQT2016-09-24