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Light Diagnostics™ Varicella- Zoster Virus DFA Kit

Primary DI
08436037124716
Brand
Light Diagnostics™ Varicella- Zoster Virus DFA Kit
Company
EMD Millipore Corporation
Model
3430
Catalog number
3430
Device description
Varicella- Zoster Virus DFA Kit
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GQXAntiserum, Cf, Varicella-Zoster

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQXAntiserum, Cf, Varicella-ZosterMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951799000VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAYLight Diagnostics1996-03-20GQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436037124716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436037124716084360371247168436037124716

GMDN Terms#

Term, Definition table
TermDefinition
Varicella-zoster virus (VZV) antigen IVD, kit, direct fluorescent test (DFT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from varicella-zoster virus (VZV) in a clinical specimen, using a direct fluorescent test (DFT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

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
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
00894175000015AccuDiag ™Diagnostic Automation, Inc.GQX2023-06-14
04053252285547Light Diagnostics VZV Control Slides (5 pack)EMD Millipore CorporationGQX2020-04-17
04053252792861Light Diagnostics VZV Control SlideEMD Millipore CorporationGQX2020-04-17
04053252732638Light Diagnostics VZV DFA ReagentEMD Millipore CorporationGQX2020-04-03
00840733101212MERIFLUOR VZV (Vericella-Zoster Virus)MERIDIAN BIOSCIENCE, INC.GQX2016-09-23
05391516743525Trinity BiotechCLARK LABORATORIES, INC.GQX2016-09-23
05391516747066Trinity BiotechCLARK LABORATORIES, INC.GQX2016-09-23