FDA.reportPublic FDA data

Light Diagnostics ™ SimulFluor® Respiratory Screen Kit

Primary DI
04053252473166
Brand
Light Diagnostics ™ SimulFluor® Respiratory Screen Kit
Company
EMD Millipore Corporation
Model
3296-2ML
Catalog number
3296-2ML
Device description
SimulFluor® Respiratory Screen Kit
Published
2022-12-01
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
GNYAntisera, Fluorescent, Adenovirus 1-33

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNYAntisera, Fluorescent, Adenovirus 1-33Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053252473166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053252473166040532524731664053252473166

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
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
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
04053252368165Light Diagnostics ™ SimulFluor® Flu A/Flu B Reagent525052502022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ENTIADVG00100NovaLisa Adenovirus IgGGold Standard Diagnostics Frankfurt GmbHGNY2024-08-26
ENTIADVG0010NovaLisa Adenovirus IgGGold Standard Diagnostics Frankfurt GmbHGNY2024-08-26
04048474034448Adenovirus Antigen (stool) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungGNY2023-08-29
04053252286575Light Diagnostics ™ Respiratory Viral Control Slides (8 Well)EMD Millipore CorporationGNY2022-12-01
04053252507007Light Diagnostics ™ Respiratory Screen DFA ReagentEMD Millipore CorporationGNY2022-12-01
04053252508295Light Diagnostics ™ Adenovirus Control SlidesEMD Millipore CorporationGNY2022-12-01
04061839705098Light Diagnostics ™ SimulFluor® Respiratory Screen ReagentEMD Millipore CorporationGNY2022-12-01
04053252284311Light Diagnostics ™ Normal Mouse AntibodyEMD Millipore CorporationGNY2022-11-30
04053252407239Light Diagnostics ™ SimulFluor® Respiratory Screen ReagentEMD Millipore CorporationGNY2022-11-30
04053252586392Light Diagnostics ™ Respiratory Screen DFA ReagentEMD Millipore CorporationGNY2022-11-30
04053252624834Light Diagnostics ™ Adenovirus Control SlideEMD Millipore CorporationGNY2022-11-30
04053252627668Light Diagnostics ™ Adenovirus FITC-Labeled Monoclonal AntibodyEMD Millipore CorporationGNY2022-11-30
04053252789168Light Diagnostics ™ Respiratory Viral Control SlideEMD Millipore CorporationGNY2022-11-30
08436037123078Light Diagnostics ™ Goat Anti-Mouse IgG FITC-Labeled AntibodyEMD Millipore CorporationGNY2022-11-30
04053252322235Light Diagnostics™ SimulFluor® Respiratory Screen KitEMD Millipore CorporationGNY2022-11-29
04053252373411Light Diagnostics ™ Adenovirus Monoclonal AntibodyEMD Millipore CorporationGNY2022-11-29
04053252675546Light Diagnostics ™ Respiratory Viral ScreenEMD Millipore CorporationGNY2022-11-29
04053252362064Light Diagnostics™ Respiratory Panel DFA KitEMD Millipore CorporationGNY2022-11-28
04053252589676Light Diagnostics™ Respiratory Viral Screen IFA KitEMD Millipore CorporationGNY2022-11-28
08436037122651Light Diagnostics™ Respiratory Panel Viral Screening and Identification IFA KitEMD Millipore CorporationGNY2022-11-28
08436037124617Light Diagnostics™ Adenovirus DFA KitEMD Millipore CorporationGNY2022-11-28
08436037124631Light Diagnostics™ Respiratory Panel Viral Screening and Identification DFA KitEMD Millipore CorporationGNY2022-11-28
08436037124914Light Diagnostics™ Respiratory Viral Screen DFA KitEMD Millipore CorporationGNY2022-11-28
00840239034441Adenovirus Antigen (stool) ELISADRG International IncGNY2021-06-07
30014613330844D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNY2019-03-07
30014613330851D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNY2019-03-07
30014613330868D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNY2019-03-07
30014613330875D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNY2019-03-07
30014613330769D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNY2018-07-22
30014613330776D3 FastpointDIAGNOSTIC HYBRIDS, INC.GNY2018-07-22