FDA.reportPublic FDA data

Anti-Measles virus IFA (IgM)

Primary DI
04049016057277
Brand
Anti-Measles virus IFA (IgM)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
FI 2610-1005 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
GREAntiserum, Fluorescent, Rubeola

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GREAntiserum, Fluorescent, RubeolaMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016057277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016057277040490160572774049016057277

GMDN Terms#

Term, Definition table
TermDefinition
Measles 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 Measles 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
G5229031001Measles IgG IFA 96 TestHemagen Diagnostics, Inc.GRE2023-10-05
G5229031011Measles IgG IFA Slide Only KitHemagen Diagnostics, Inc.GRE2023-10-05
04053252403323Light Diagnostics ™ Measles Control SlidesEMD Millipore CorporationGRE2022-12-01
04053252475276Light Diagnostics ™ Measles Monoclonal AntibodyEMD Millipore CorporationGRE2022-11-30
04053252783180Light Diagnostics ™ Measles Control SlideEMD Millipore CorporationGRE2022-11-30
04053252283840Light Diagnostics™ Measles IFA KitEMD Millipore CorporationGRE2022-11-28
04049016057222Anti-Measles virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRE2016-09-24
04049016057239Anti-Measles virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRE2016-09-24
04049016057246Anti-Measles virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRE2016-09-24
04049016057253Anti-Measles virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRE2016-09-24
04049016057260Anti-Measles virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRE2016-09-24
04049016057284Anti-Measles virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRE2016-09-24
04049016057291Anti-Measles virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRE2016-09-24
04049016079422Anti-Measles virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRE2016-09-24
00813545026004Measles IgG 120 Test Kit SCIMEDX CORPORATIONGRE2016-09-21
00813545026028Measles 10 Well; 10 pk SCIMEDX CORPORATIONGRE2016-09-21
B110ME60120Measles (Rubeola) Virus Antigen Substrate, 12 wells, For IFA Test SystemBion Enterprises, Ltd.GRE2016-09-12
B110MEG1200Measles IgG Test System, 120 TestsBion Enterprises, Ltd.GRE2016-09-12
B110MEG60200Measles IgG ControlBion Enterprises, Ltd.GRE2016-09-12
B110MEM1200Measles IgM Test System, 120 TestsBion Enterprises, Ltd.GRE2016-09-12
B110MEM60300Measles IgM ControlBion Enterprises, Ltd.GRE2016-09-12
B110MEN60100Measles Negative ControlBion Enterprises, Ltd.GRE2016-09-12
B110ME60060Measles (Rubeola) Virus Antigen Substrate, 6 wells, For IFA Test SystemBion Enterprises, Ltd.GRE2016-08-02