FDA.reportPublic FDA data

Light Diagnostics Human Metapneumovirus (hMPV) Control Slides (5 pack)

Primary DI
04053252518584
Brand
Light Diagnostics Human Metapneumovirus (hMPV) Control Slides (5 pack)
Company
EMD Millipore Corporation
Model
5092-5
Catalog number
5092-5
Device description
Human Metapneumovirus Control Slides
Published
2020-04-16
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
OMGAntisera, Fluorescent, Human Metapneumovirus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMGAntisera, Fluorescent, Human MetapneumovirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093815000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093815000LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124Millipore Corporation2010-03-12OMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053252518584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053252518584040532525185844053252518584

GMDN Terms#

Term, Definition table
TermDefinition
Human metapneumovirus (hMPV) 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 human metapneumovirus (hMPV) 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
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
04053252279362Light Diagnostics hMPV DFA ReagentEMD Millipore CorporationOMG2020-04-17
04061841047452Light Diagnostics hMPV Control SlideEMD Millipore CorporationOMG2020-04-17
30014613330844D3 FastpointDIAGNOSTIC HYBRIDS, INC.OMG2019-03-07
30014613330851D3 FastpointDIAGNOSTIC HYBRIDS, INC.OMG2019-03-07
30014613330868D3 FastpointDIAGNOSTIC HYBRIDS, INC.OMG2019-03-07
30014613330875D3 FastpointDIAGNOSTIC HYBRIDS, INC.OMG2019-03-07
30014613330523D3DIAGNOSTIC HYBRIDS, INC.OMG2018-08-07
30014613330530D3DIAGNOSTIC HYBRIDS, INC.OMG2018-08-07
30014613330769D3 FastpointDIAGNOSTIC HYBRIDS, INC.OMG2018-07-22
30014613330776D3 FastpointDIAGNOSTIC HYBRIDS, INC.OMG2018-07-22
30014613330820D3 FastpointDIAGNOSTIC HYBRIDS, INC.OMG2018-07-22
30014613330837D3 FastpointDIAGNOSTIC HYBRIDS, INC.OMG2018-07-22
04053252282133Light Diagnostics™ Human Metapneumovirus Direct Immunofluorescence AssayEMD Millipore CorporationOMG2016-09-23
30014613330516D3DIAGNOSTIC HYBRIDS, INC.OMG2016-09-15
30014613330752D3 FastpointDIAGNOSTIC HYBRIDS, INC.OMG2016-09-15
30014613330813D3 FastpointDIAGNOSTIC HYBRIDS, INC.OMG2016-09-15