FDA.reportPublic FDA data

Light Diagnostics™ Respiratory Syncytial Virus DFA Kit

Primary DI
08436037124624
Brand
Light Diagnostics™ Respiratory Syncytial Virus DFA Kit
Company
EMD Millipore Corporation
Model
3125
Catalog number
3125
Device description
Respiratory Syncytial Virus DFA 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKTRespiratory Syncytial Virus, Antigen, Antibody, IfaMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436037124624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436037124624084360371246248436037124624

GMDN Terms#

Term, Definition table
TermDefinition
Multiple respiratory virus antigen IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antigens from viruses associated with respiratory diseases in a clinical specimen, using a fluorescent immunoassay method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

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
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
04053252286612Light Diagnostics ™ Pan-Enterovirus Control Slides5069-55069-52022-12-05
04053252471827Light Diagnostics ™ Pan-Enterovirus Reagent 3360-10ML3360-10ML2022-12-05
04061841171201Light Diagnostics ™ Poliovirus Control Slide50206502062022-12-05
04061841171225Light Diagnostics ™ Echovirus Control Slide50207502072022-12-05
04061841171478Light Diagnostics ™ Enterovirus70/71 Control Slide50266502662022-12-05
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
04053252357497Light Diagnostics™Mouse Anti-Rabies Monoclonal Antibody; Clone Name C18-62-143-2MAB8724MAB87242022-12-01
04053252360862Light Diagnostics ™ Mouse Anti-Cytomegalovirus Monoclonal AntibodyMAB810-500UGMAB810-500UG2022-12-01
04053252364068Light Diagnostics ™ Mumps Control Slides5029-55029-52022-12-01
04053252373435Light Diagnostics ™ Influenza A & B Control Slides5010-55010-52022-12-01
04053252399756Light Diagnostics™ Mouse Anti-Rabies Monoclonal Antibody; Clone Name C10-62-52-2MAB8722MAB87222022-12-01
04053252403323Light Diagnostics ™ Measles Control Slides5031-55031-52022-12-01
04053252473166Light Diagnostics ™ SimulFluor® Respiratory Screen Kit3296-2ML3296-2ML2022-12-01
04053252505522Light Diagnostics™ Mouse Anti-Rabies Monoclonal Antibody; Clone Name C15-62-97-3MAB8723MAB87232022-12-01
04053252507007Light Diagnostics ™ Respiratory Screen DFA Reagent5307-2ML5307-2ML2022-12-01
04053252508295Light Diagnostics ™ Adenovirus Control Slides5009-55009-52022-12-01
04053252576775Light Diagnostics ™ Mouse Anti-Rabies Monoclonal Antibody; Clone Name C2-62-8-2MAB8719MAB87192022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053252282393Light Diagnostics ™ Respiratory Syncytial Virus (RSV) Control SlidesEMD Millipore CorporationLKT2022-12-01
04053252332555Light Diagnostics ™ SimulFluor® RSV/Para 3 ReagentEMD Millipore CorporationLKT2022-11-30
04053252472978Light Diagnostics ™ RSV FITC-Labeled Monoclonal AntibodyEMD Millipore CorporationLKT2022-11-30
04053252783234Light Diagnostics ™ Respiratory syncytial Virus (RSV) Control SlideEMD Millipore CorporationLKT2022-11-30
04053252589591Light Diagnostics ™ RSV Monoclonal Antibody EMD Millipore CorporationLKT2022-11-29
04053252732294Light Diagnostics™ SimulFluor® RSV/Para 3 DFA KitEMD Millipore CorporationLKT2022-11-28
05056080501680PathoDX Respiratory Viral PanelREMEL EUROPE LIMITEDLKT2021-07-21
05056080501697PathoDX Influenza A ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501703PathoDX Influenza B ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501710PathoDX Adenovirus ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501727PathoDx Parainfluenza 1 ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501734PathoDx Parainfluenza 2 ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501741PathoDx Parainfluenza 3 ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501758PathoDX RSV ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501765PathoDX Respiratory Mounting FluidREMEL EUROPE LIMITEDLKT2021-07-21
05056080501772PathoDX RVP Control SlidesREMEL EUROPE LIMITEDLKT2021-07-21
05056080501789PathoDX RSV Direct SpecimenREMEL EUROPE LIMITEDLKT2021-07-21
05056080501796 PathoDX RSV Control SlidesREMEL EUROPE LIMITEDLKT2021-07-21
30014613330950D3DIAGNOSTIC HYBRIDS, INC.LKT2019-04-19
30014613330844D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330851D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330868D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330899D3 DuetDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330905D3 DuetDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330912D3 DuetDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330929D3 DuetDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330776D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2018-07-22
30014613330820D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2018-07-22
30014613330837D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2018-07-22
04049016059226Anti-RSV IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKT2016-09-24