FDA.reportPublic FDA data

VIDAS® Measles IgG

Primary DI
03573026064532
Brand
VIDAS® Measles IgG
Company
BIOMERIEUX SA
Model
30219
Device description
VIDAS Measles IgG (MSG) assay is a qualitative IA intended for use on VIDAS family instrument in the detection of IgG antibodies to measles (rubeola) in human serum.
Published
2019-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LJBEnzyme linked immunoabsorbent assay, rubeola IgG

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJBEnzyme Linked Immunoabsorbent Assay, Rubeola IggMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026064532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026064532035730260645323573026064532

GMDN Terms#

Term, Definition table
TermDefinition
Measles virus immunoglobulin G (IgG) 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 G (IgG) antibodies to Measles 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
276816717
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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ENTIMEAG0330NovaLisa Measles Virus IgGGold Standard Diagnostics Frankfurt GmbHLJB2024-08-26
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00840239038449Measles Virus IgG ELISADRG International IncLJB2019-03-20
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