FDA.reportPublic FDA data

Mumps IgM ELISA

Primary DI
00840239038470
Brand
Mumps IgM ELISA
Company
DRG International Inc
Model
EIA-3847
Catalog number
EIA-3847
Device description
The Mumps Virus IgM ELISA is intended for the qualitative determination of IgM class antibodies against Mumps Virus in human serum or plasma (citrate, heparin).
Published
2024-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LJYEnzyme Linked Immunoabsorbent Assay, Mumps Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJYEnzyme Linked Immunoabsorbent Assay, Mumps VirusMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239038470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239038470008402390384708402390384700840239038470

GMDN Terms#

Term, Definition table
TermDefinition
Mumps virus immunoglobulin A (IgA)/IgG/IgM 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), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Mumps 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
075150847
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239059673Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-08-26
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ENTIMUMG03400NovaLisa Mumps Virus IgGGold Standard Diagnostics Frankfurt GmbHLJY2024-08-26
ENTIMUMG0340NovaLisa Mumps Virus IgGGold Standard Diagnostics Frankfurt GmbHLJY2024-08-26
04048474038477Mumps IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJY2024-08-20
08033891322458CHORUS MUMPS IgGDIESSE DIAGNOSTICA SENESE SPALJY2024-01-22
00847865010771Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LJY2023-01-04
00894175000060AccuDiag ™ Diagnostic Automation, Inc.LJY2021-08-10
B3507205400Gold Standard Diagnostics Is-Mumps IgG ELISA Test KitGold Standard Diagnostics CorporationLJY2020-07-27
05391516743600Trinity BiotechCLARK LABORATORIES, INC.LJY2019-10-25
03573026064525VIDAS® Mumps IgGBIOMERIEUX SALJY2019-09-16
04048474038460Mumps Virus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJY2019-06-05
00404847438468Mumps Virus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJY2019-06-05
00840239038463Mumps Virus IgG ELISADRG International IncLJY2019-03-20
05391516747110Trinity BiotechCLARK LABORATORIES, INC.LJY2017-05-07
04049016028017Anti-Mumps Virus ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJY2016-09-24
04049016028024Anti-Mumps Virus ELISA (IgM)EUROIMMUN Medizinische Labordiagnostika AGLJY2016-09-24
04049016083283Anti-Mumps Virus AT ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLJY2016-09-24
04049016103646Anti-Mumps Virus ELISA (G5) (IgM)EUROIMMUN Medizinische Labordiagnostika AGLJY2016-09-24
05391516743617Trinity BiotechCLARK LABORATORIES, INC.LJY2016-09-23
05391516743624Trinity BiotechCLARK LABORATORIES, INC.LJY2016-09-23
00817273020310DiamedixDIAMEDIX CORPORATIONLJY2016-09-20
00847865000727BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
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00847865000741BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
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00847865002189BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865002264BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865002332BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865010979BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00850487007081ReQuest QUEST INTERNATIONAL, INC.LJY2016-08-31