FDA.reportPublic FDA data

Mumps Virus IgG ELISA

Primary DI
00404847438468
Brand
Mumps Virus IgG ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
N/A
Catalog number
EIA-3846
Device description
The Mumps Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Mumps Virus in human serum or plasma (citrate, heparin).
Published
2019-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
00404847438468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00404847438468004048474384684048474384680404847438468

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/or 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

Contacts#

Phone, Email table
PhoneEmail
+1(973)564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
317134468
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048474041170ANA Detect ELISAEIA-4117EIA-41172023-08-31
04048474027730ANA Screen IgG ELISA EIA-2773EIA-27732023-08-29
04048474035629ANA-8-Screen ELISAEIA-3562EIA-35622019-06-05
04048474035636ANA Combi (ANA-8-Profile) ELISAEIA-3563EIA-35632019-06-10
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474059670Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-09-01
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-09-01
04048474027747DNA (ds) IgG ELISAEIA-2774EIA-27742023-08-29
04048474027938Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-29
04048474027945Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-29
04048474027969EBV-EA IgG ELISAEIA-2796EIA-27962023-08-29
04048474028157H. Pylori IgG ELISA EIA-2815EIA-28152023-08-29
04048474033717Gliadin IgG ELISA EIA-3371EIA-33712023-08-29
04048474034448Adenovirus Antigen (stool) ELISA EIA-3444EIA-34442023-08-29
04048474034677Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-29
04048474034738Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-29
04048474034776Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-29
04048474036022Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-29
04048474035520hGH ELISAEIA-3552EIA-35522019-06-10
04048474035612Anti TPO Ab ELISAEIA-3561EIA-35612019-06-10

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
00840239038470Mumps IgM ELISADRG International IncLJY2024-08-20
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
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
00847865000734BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865000741BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865000758BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
00847865000765BioPlex 2200BIO-RAD LABORATORIES, INC.LJY2016-09-12
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