FDA.reportPublic FDA data

Light Diagnostics ™ SimulFluor® Parainfluenza 1, 2/3 Reagent

Primary DI
04053252403040
Brand
Light Diagnostics ™ SimulFluor® Parainfluenza 1, 2/3 Reagent
Company
EMD Millipore Corporation
Model
5297
Catalog number
5297
Device description
SimulFluor® Parainfluenza 1, 2/3 Reagent
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
GQTAntisera, Cf, Parainfluenza Virus 1-4

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQTAntisera, Cf, Parainfluenza Virus 1-4Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053252403040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053252403040040532524030404053252403040

GMDN Terms#

Term, Definition table
TermDefinition
Influenza/parainfluenza virus antigen IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from influenza and parainfluenza viruses [e.g., influenza A, influenza B, human parainfluenza virus 1 (HPIV-1), human parainfluenza virus 2 (HPIV-2)] in a clinical specimen, using an enzyme immunoassay (EIA) 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
04053252325519Light Diagnostics ™ Parainfluenza 1, 2, 3 Control SlidesEMD Millipore CorporationGQT2022-12-01
04053252670114Light Diagnostics ™ Parainfluenza 4 Control Slides (5 Pack)EMD Millipore CorporationGQT2022-12-01
04053252280238Light Diagnostics ™ Parainfluenza 3 FITC-Labeled Monoclonal AntibodyEMD Millipore CorporationGQT2022-11-30
04053252362224Light Diagnostics ™ Parainfluenza 2 FITC-Labeled Monoclonal AntibodyEMD Millipore CorporationGQT2022-11-30
04053252471469Light Diagnostics ™ Parainfluenza Pan FITC-Labeled Monoclonal AntibodiesEMD Millipore CorporationGQT2022-11-30
04053252728365Light Diagnostics ™ Para 4 DFA ReagentEMD Millipore CorporationGQT2022-11-30
04053252730818Light Diagnostics ™ Parainfluenza 1 FITC-Labeled Monoclonal AntibodyEMD Millipore CorporationGQT2022-11-30
04053252739583Light Diagnostics ™ SimulFluor® Para 1, 2, 3/ Adeno ReagentEMD Millipore CorporationGQT2022-11-30
04053252783258Light Diagnostics ™ Para-influenza 1, 2, 3 Control SlideEMD Millipore CorporationGQT2022-11-30
04061841171485Light Diagnostics ™ Para 4 Control SlideEMD Millipore CorporationGQT2022-11-30
04053252322273Light Diagnostics ™ Parainfluenza 2 Monoclonal AntibodyEMD Millipore CorporationGQT2022-11-29
04053252513121Light Diagnostics™ SimulFluor® Para 1, 2, 3/ Adeno DFA KitEMD Millipore CorporationGQT2022-11-29
04053252672743Light Diagnostics ™ Parainfluenza 1 Monoclonal AntibodyEMD Millipore CorporationGQT2022-11-29
04053252728358Light Diagnostics™ SimulFluor® Parainfluenza 1, 2 /3 DFA KitEMD Millipore CorporationGQT2022-11-29
04053252738081Light Diagnostics ™ Parainfluenza 2 Monoclonal AntibodyEMD Millipore CorporationGQT2022-11-29
08436037124891Light Diagnostics™ Parainfluenza 1, 2, and 3 DFA KitEMD Millipore CorporationGQT2022-11-28
04049016028369Anti-Parainfluenza Viruses Pool ELISA (IgA)EUROIMMUN Medizinische Labordiagnostika AGGQT2016-09-24
04049016028376Anti-Parainfluenza Viruses Pool ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGQT2016-09-24
04049016028383Anti-Parainfluenza Viruses Pool ELISA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGQT2016-09-24