FDA.reportPublic FDA data

PathoDX Adenovirus Reagent

Primary DI
05056080501710
Brand
PathoDX Adenovirus Reagent
Company
REMEL EUROPE LIMITED
Model
R62407
Published
2021-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKTRespiratory Syncytial Virus, Antigen, Antibody, IfaMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983336000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983336000PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1Diagnostic Products Corp.1999-03-18LKT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056080501710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056080501710050560805017105056080501710

GMDN Terms#

Term, Definition table
TermDefinition
Multiple respiratory virus antigen IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple antigens from viruses associated with respiratory diseases in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401256694238microbiology.techsupport.uk@thermofisher.com

Regulatory Flags#

DUNS number
232600853
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056080500928Shigella boydii polyvalent 1 (1-6) Agglutinating SerumR301639012026-05-05
05056080501024NAR301650012016-12-09
05056080501888Wellcolex E.coli O157R309595012021-07-21
05056080501598Proteus OX2 Agglutinating SerumR301657012021-07-21
05056080500065NAR308550012016-09-24
05056080500126NAR308553012016-09-24
05056080500317NAR309577012016-09-24
05056080500324NAR309578012016-09-24
05056080500331NAR309579012016-09-24
05056080500348NAR309580012016-09-24
05056080500379NAR309583012016-09-24
05056080500409NAR309586012016-09-24
05056080500591NAR301606012016-09-24
05056080500607NAR301607012016-09-24
05056080500614NAR301608012016-09-24
05056080500638NAR301610012016-09-24
05056080500645NAR301611012016-09-24
05056080500652NAR301612012016-09-24
05056080500713NAR301618012016-09-24
05056080500768NAR301623012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053252282393Light Diagnostics ™ Respiratory Syncytial Virus (RSV) Control SlidesEMD Millipore CorporationLKT2022-12-01
04053252332555Light Diagnostics ™ SimulFluor® RSV/Para 3 ReagentEMD Millipore CorporationLKT2022-11-30
04053252472978Light Diagnostics ™ RSV FITC-Labeled Monoclonal AntibodyEMD Millipore CorporationLKT2022-11-30
04053252783234Light Diagnostics ™ Respiratory syncytial Virus (RSV) Control SlideEMD Millipore CorporationLKT2022-11-30
04053252589591Light Diagnostics ™ RSV Monoclonal Antibody EMD Millipore CorporationLKT2022-11-29
04053252732294Light Diagnostics™ SimulFluor® RSV/Para 3 DFA KitEMD Millipore CorporationLKT2022-11-28
08436037124624Light Diagnostics™ Respiratory Syncytial Virus DFA KitEMD Millipore CorporationLKT2022-11-28
05056080501680PathoDX Respiratory Viral PanelREMEL EUROPE LIMITEDLKT2021-07-21
05056080501697PathoDX Influenza A ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501703PathoDX Influenza B ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501727PathoDx Parainfluenza 1 ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501734PathoDx Parainfluenza 2 ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501741PathoDx Parainfluenza 3 ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501758PathoDX RSV ReagentREMEL EUROPE LIMITEDLKT2021-07-21
05056080501765PathoDX Respiratory Mounting FluidREMEL EUROPE LIMITEDLKT2021-07-21
05056080501772PathoDX RVP Control SlidesREMEL EUROPE LIMITEDLKT2021-07-21
05056080501789PathoDX RSV Direct SpecimenREMEL EUROPE LIMITEDLKT2021-07-21
05056080501796 PathoDX RSV Control SlidesREMEL EUROPE LIMITEDLKT2021-07-21
30014613330950D3DIAGNOSTIC HYBRIDS, INC.LKT2019-04-19
30014613330844D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330851D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330868D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330875D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330899D3 DuetDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330905D3 DuetDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330912D3 DuetDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330929D3 DuetDIAGNOSTIC HYBRIDS, INC.LKT2019-03-07
30014613330769D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2018-07-22
30014613330776D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2018-07-22
30014613330820D3 FastpointDIAGNOSTIC HYBRIDS, INC.LKT2018-07-22