FDA.report

Light Diagnostics™ Mumps IFA Kit

Primary DI
04053252329746
Brand
Light Diagnostics™ Mumps IFA Kit
Company
EMD Millipore Corporation
Model
3140
Catalog number
3140
Device description
Mumps IFA Kit
Published
2022-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GRAAntiserum, Fluorescent, Mumps Virus

Product Code Classifications

CodeDeviceSpecialtyClass
GRAAntiserum, Fluorescent, Mumps VirusMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04053252329746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04053252329746040532523297464053252329746

GMDN Terms

TermDefinition
Mumps virus immunoglobulin A (IgA)/IgG/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 A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Mumps virus in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1 (951) 676-8080R128863@merckgroup.com

Regulatory Flags

DUNS number
829517072
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04061839704138Light Diagnostics ™ Mumps Control SlideEMD Millipore CorporationGRA2022-11-30
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