FDA.reportPublic FDA data

Light Diagnostics ™ Mumps Monoclonal Antibody

Primary DI
04053252282713
Brand
Light Diagnostics ™ Mumps Monoclonal Antibody
Company
EMD Millipore Corporation
Model
5028
Catalog number
5028
Device description
Mumps Monoclonal Antibody
Published
2022-11-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04053252282713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053252282713040532522827134053252282713

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 (951) 676-8080R128863@merckgroup.com

Regulatory Flags#

DUNS number
829517072
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053252732638Light Diagnostics VZV DFA Reagent509450942020-04-03
04053252282133Light Diagnostics™ Human Metapneumovirus Direct Immunofluorescence Assay312431242016-09-23
04053252371745Light Diagnostics™ Simulfluor® HSV / VZV DFA 329532952016-09-09
04053252401121Light Diagnostics™ Pneumocystis Carinii DFA 319531952016-09-26
04061839405141MIDAS® III-Plus Automated Stainer64000H-942022-06-28
04053252270239Light Diagnostics ™ SimulFluor® Flu A / Flu B Reagent5250-5ML5250-5ML2022-12-01
04053252282393Light Diagnostics ™ Respiratory Syncytial Virus (RSV) Control Slides5012-55012-52022-12-01
04053252286575Light Diagnostics ™ Respiratory Viral Control Slides (8 Well)5071-105071-102022-12-01
04053252325519Light Diagnostics ™ Parainfluenza 1, 2, 3 Control Slides5011-55011-52022-12-01
04053252373435Light Diagnostics ™ Influenza A & B Control Slides5010-55010-52022-12-01
04053252473166Light Diagnostics ™ SimulFluor® Respiratory Screen Kit3296-2ML3296-2ML2022-12-01
04053252507007Light Diagnostics ™ Respiratory Screen DFA Reagent5307-2ML5307-2ML2022-12-01
04053252508295Light Diagnostics ™ Adenovirus Control Slides5009-55009-52022-12-01
04053252670114Light Diagnostics ™ Parainfluenza 4 Control Slides (5 Pack)5098-55098-52022-12-01
04061839705098Light Diagnostics ™ SimulFluor® Respiratory Screen Reagent5296-2ML5296-2ML2022-12-01
04053252280238Light Diagnostics ™ Parainfluenza 3 FITC-Labeled Monoclonal Antibody502150212022-11-30
04053252284311Light Diagnostics ™ Normal Mouse Antibody501450142022-11-30
04053252320439Light Diagnostics ™ Influenza A FITC-Labeled Monoclonal Antibody501750172022-11-30
04053252332555Light Diagnostics ™ SimulFluor® RSV/Para 3 Reagent524052402022-11-30
04053252362224Light Diagnostics ™ Parainfluenza 2 FITC-Labeled Monoclonal Antibody502050202022-11-30

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
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
00813545026035Mumps IgG 120 Test Kit SCIMEDX CORPORATIONGRA2016-09-21
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