FDA.reportPublic FDA data

Anti-Mumps virus IFA (IgM)

Primary DI
04049016057529
Brand
Anti-Mumps virus IFA (IgM)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
FI 2630-1010 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
GRAAntiserum, Fluorescent, Mumps Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GRAAntiserum, Fluorescent, Mumps VirusMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016057529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016057529040490160575294049016057529

GMDN Terms#

Term, Definition table
TermDefinition
Mumps virus immunoglobulin M (IgM) 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 M (IgM) antibodies to Mumps virus 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
G5229032001Mumps IgG IFA 96 TestHemagen Diagnostics, Inc.GRA2023-10-05
G5229032011Mumps IgG IFA Slide Only KitHemagen Diagnostics, Inc.GRA2023-10-05
04053252364068Light Diagnostics ™ Mumps Control SlidesEMD Millipore CorporationGRA2022-12-01
04053252282713Light Diagnostics ™ Mumps Monoclonal AntibodyEMD Millipore CorporationGRA2022-11-30
04061839704138Light Diagnostics ™ Mumps Control SlideEMD Millipore CorporationGRA2022-11-30
04053252329746Light Diagnostics™ Mumps IFA KitEMD Millipore CorporationGRA2022-11-28
04049016057468Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057475Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057482Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057499Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057505Anti-Mumps virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057512Anti-Mumps virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057536Anti-Mumps virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016079514Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
00813545026035Mumps IgG 120 Test Kit SCIMEDX CORPORATIONGRA2016-09-21
00813545026059Mumps 10 Well; 10 pk SCIMEDX CORPORATIONGRA2016-09-21
B110MU80060Mumps Virus Antigen Substrate, 6 wells, For IFA Test SystemBion Enterprises, Ltd.GRA2016-09-12
B110MU80120Mumps Virus Antigen Substrate, 12 wells, For IFA Test SystemBion Enterprises, Ltd.GRA2016-09-12
B110MUG1200Mumps IgG Test System, 120 TestsBion Enterprises, Ltd.GRA2016-09-12
B110MUG600Mumps IgG Test System, 60 TestsBion Enterprises, Ltd.GRA2016-09-12
B110MUG80200Mumps IgG ControlBion Enterprises, Ltd.GRA2016-09-12
B110MUM80300Mumps IgM ControlBion Enterprises, Ltd.GRA2016-09-12
B110MUN80100Mumps Negative ControlBion Enterprises, Ltd.GRA2016-09-12