FDA.reportPublic FDA data

Light Diagnostics ™ Enterovirus Screening Kit

Primary DI
04053252279973
Brand
Light Diagnostics ™ Enterovirus Screening Kit
Company
EMD Millipore Corporation
Model
3465
Catalog number
3465
Device description
Enterovirus Screening Kit
Published
2022-11-29
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
GOEAntisera, Fluorescent, Poliovirus 1-3

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GOEAntisera, Fluorescent, Poliovirus 1-3Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053252279973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053252279973040532522799734053252279973

GMDN Terms#

Term, Definition table
TermDefinition
Enterovirus antigen (serotypes 68-71) 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 enterovirus antigens from serotypes 68-71 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
Kit
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
30014613330486D3DIAGNOSTIC HYBRIDS, INC.GOE2023-07-10
04053252286612Light Diagnostics ™ Pan-Enterovirus Control SlidesEMD Millipore CorporationGOE2022-12-05
04053252471827Light Diagnostics ™ Pan-Enterovirus Reagent EMD Millipore CorporationGOE2022-12-05
04061841171201Light Diagnostics ™ Poliovirus Control SlideEMD Millipore CorporationGOE2022-12-05
04061841171478Light Diagnostics ™ Enterovirus70/71 Control SlideEMD Millipore CorporationGOE2022-12-05
04053252476464Light Diagnostics ™ Poliovirus Control SlidesEMD Millipore CorporationGOE2022-11-30
04053252625091Light Diagnostics ™ Enterovirus 70/71 Control Slides EMD Millipore CorporationGOE2022-11-30
04053252675706Light Diagnostics ™ Enterovirus Slide PackageEMD Millipore CorporationGOE2022-11-30
04061839700550Light Diagnostics ™ Pan-Enterovirus Control SlideEMD Millipore CorporationGOE2022-11-30
04053252277030Light Diagnostics ™ Pan-Enterovirus 2E11 Monoclonal AntibodyEMD Millipore CorporationGOE2022-11-29
04053252280085Light Diagnostics ™ Pan-Enterovirus Detection KitEMD Millipore CorporationGOE2022-11-29
04053252321078Light Diagnostics ™ Enterovirus 70 and 71 or Coxsackie A16 BlendEMD Millipore CorporationGOE2022-11-29
04053252321696Light Diagnostics ™ Poliovirus Antibody SetEMD Millipore CorporationGOE2022-11-29
04053252338243Light Diagnostics ™ Poliovirus BlendEMD Millipore CorporationGOE2022-11-29
04053252369407Light Diagnostics ™ Poliovirus 1 Monoclonal AntibodyEMD Millipore CorporationGOE2022-11-29
04053252469404Light Diagnostics ™ Enterovirus 71/ Coxsackie A16 Monoclonal AntibodyEMD Millipore CorporationGOE2022-11-29
04053252474262Light Diagnostics ™ Pan-Enterovirus 9D5EMD Millipore CorporationGOE2022-11-29
04053252581069Light Diagnostics ™ Pan-Enterovirus Reagent EMD Millipore CorporationGOE2022-11-29
04053252619441Light Diagnostics ™ Enterovirus 70 Monoclonal AntibodyEMD Millipore CorporationGOE2022-11-29
04053252624155Light Diagnostics ™ Enterovirus 71 Monoclonal AntibodyEMD Millipore CorporationGOE2022-11-29
04053252671012Light Diagnostics ™ Enterovirus 70/71 Antibody SetEMD Millipore CorporationGOE2022-11-29
04053252673146Light Diagnostics ™ Poliovirus 3 Monoclonal AntibodyEMD Millipore CorporationGOE2022-11-29
04053252677649Light Diagnostics ™ Poliovirus 2 Monoclonal AntibodyEMD Millipore CorporationGOE2022-11-29
08436037124600Light Diagnostics ™ Enterovirus Screening SetEMD Millipore CorporationGOE2022-11-29
30014613330646D3DIAGNOSTIC HYBRIDS, INC.GOE2019-04-19
30014613330653D3DIAGNOSTIC HYBRIDS, INC.GOE2019-04-19
30014613330561D3DIAGNOSTIC HYBRIDS, INC.GOE2019-03-07
30014613330578D3DIAGNOSTIC HYBRIDS, INC.GOE2019-03-07
30014613330585D3DIAGNOSTIC HYBRIDS, INC.GOE2019-03-07
30014613330592D3DIAGNOSTIC HYBRIDS, INC.GOE2019-03-07