FDA.reportPublic FDA data

Mumps IgG 120 Test Kit

Primary DI
00813545026035
Brand
Mumps IgG 120 Test Kit
Company
SCIMEDX CORPORATION
Model
I-MUV01G
Catalog number
I-MUV01G
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GRAAntiserum, Fluorescent, Mumps Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GRAAntiserum, Fluorescent, Mumps VirusMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813545026035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813545026035008135450260358135450260350813545026035

GMDN Terms#

Term, Definition table
TermDefinition
Mumps virus immunoglobulin G (IgG) 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 G (IgG) antibodies to Mumps virus in a clinical specimen, using a fluorescent immunoassay method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002215598service@scimedx.com

Regulatory Flags#

DUNS number
155424708
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
00813545026905MeDiCa1001-481001-482020-11-04
00813545026912MeDiCa1001-961001-962020-11-04
00813545026561MeDiCa010101012020-12-01
00813545026578MeDiCa010201022020-12-01
00813545026776MeDiCa082108212020-12-01
00813545026783MeDiCa082208222020-12-01
00813545026790MeDiCa0821-M0821-M2020-12-01
00813545026806MeDiCa0822-M0822-M2020-12-01
00813545026813MeDiCa083108312020-12-01
00813545026820MeDiCa083208322020-12-01
00813545026837MeDiCa0831-M0831-M2020-12-01
00813545026844MeDiCa0832-M0832-M2020-12-01
00813545026851MeDiCa083308332020-12-01
00813545026868MeDiCa0833-M0833-M2020-12-01
00813545026875MeDiCa083408342020-12-01
00813545026882MeDiCa0834-M0834-M2020-12-01
00813545026899MeDiCa0842-RM0842-M2020-12-01
00813545027223MeDiCa8021-488021-482020-12-01
00813545027261MeDiCa8021-4008021-4002020-12-01
00813545027278MeDiCa8021-96-GI8021-96-GI2020-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G5229032001Mumps IgG IFA 96 TestHemagen Diagnostics, Inc.GRA2023-10-05
G5229032011Mumps IgG IFA Slide Only KitHemagen Diagnostics, Inc.GRA2023-10-05
04053252364068Light Diagnostics ™ Mumps Control SlidesEMD Millipore CorporationGRA2022-12-01
04053252282713Light Diagnostics ™ Mumps Monoclonal AntibodyEMD Millipore CorporationGRA2022-11-30
04061839704138Light Diagnostics ™ Mumps Control SlideEMD Millipore CorporationGRA2022-11-30
04053252329746Light Diagnostics™ Mumps IFA KitEMD Millipore CorporationGRA2022-11-28
04049016057468Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057475Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057482Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057499Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057505Anti-Mumps virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057512Anti-Mumps virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057529Anti-Mumps virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057536Anti-Mumps virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016079514Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
00813545026059Mumps 10 Well; 10 pk SCIMEDX CORPORATIONGRA2016-09-21
B110MU80060Mumps Virus Antigen Substrate, 6 wells, For IFA Test SystemBion Enterprises, Ltd.GRA2016-09-12
B110MU80120Mumps Virus Antigen Substrate, 12 wells, For IFA Test SystemBion Enterprises, Ltd.GRA2016-09-12
B110MUG1200Mumps IgG Test System, 120 TestsBion Enterprises, Ltd.GRA2016-09-12
B110MUG600Mumps IgG Test System, 60 TestsBion Enterprises, Ltd.GRA2016-09-12
B110MUG80200Mumps IgG ControlBion Enterprises, Ltd.GRA2016-09-12
B110MUM80300Mumps IgM ControlBion Enterprises, Ltd.GRA2016-09-12
B110MUN80100Mumps Negative ControlBion Enterprises, Ltd.GRA2016-09-12