FDA.reportPublic FDA data

Light Diagnostics™ Simulfluor® HSV / VZV DFA

Primary DI
04053252371745
Brand
Light Diagnostics™ Simulfluor® HSV / VZV DFA
Company
EMD Millipore Corporation
Model
3295
Catalog number
3295
Device description
Simulfluor HSV / VZV DFA Kit
Published
2016-09-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQWAntigen, Cf, (Including Cf Control), Varicella-ZosterMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990141000LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295Light Diagnostics1999-10-19GQW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053252371745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053252371745040532523717454053252371745

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) 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

Regulatory Flags#

DUNS number
829517072
Device count
1
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
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
04053252368165Light Diagnostics ™ SimulFluor® Flu A/Flu B Reagent525052502022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G5229028001Varicella-Zoster Virus / VZV IgG IFA 96 TestHemagen Diagnostics, Inc.GQW2023-10-05
G5229028011Varicella-Zoster Virus / VZV IgG IFA Slide Only KitHemagen Diagnostics, Inc.GQW2023-10-05
00860002913520ZosterGent VZV Identification ReagentVIRO RESEARCH, LLCGQW2020-10-30
00860002913537ZosterGent VZV Identification ReagentVIRO RESEARCH, LLCGQW2020-10-30
00860002913544ZosterGent VZV Identification ReagentVIRO RESEARCH, LLCGQW2020-10-30
00860002913551ZosterGent VZV Identification ReagentVIRO RESEARCH, LLCGQW2020-10-30
00860002913568ZosterGent VZV Identification ReagentVIRO RESEARCH, LLCGQW2020-10-30
00860002913513ZosterGent VZV Identification ReagentVIRO RESEARCH, LLCGQW2020-10-30
00860002913506ZosterGent VZV Identification ReagentVIRO RESEARCH, LLCGQW2020-10-30
04053252370960Light Diagnostics SimulFluor HSV/VZV ReagentEMD Millipore CorporationGQW2020-04-16
30014613330509D3DIAGNOSTIC HYBRIDS, INC.GQW2018-07-21
30014613330493D3DIAGNOSTIC HYBRIDS, INC.GQW2016-09-15
B110VZ70120Varicella Zoster Virus Antigen Substrate, 12 wells, For IFA Test SystemBion Enterprises, Ltd.GQW2016-09-12
B110VZG70200Varicella Zoster IgG ControlBion Enterprises, Ltd.GQW2016-09-12
B110VZM70300Varicella Zoster IgM ControlBion Enterprises, Ltd.GQW2016-09-12
B110VZN70100Varicella Zoster Negative ControlBion Enterprises, Ltd.GQW2016-09-12