FDA.reportPublic FDA data

Light Diagnostics ™ Coxsackievirus B3 Monoclonal Antibody

Primary DI
04053252404719
Brand
Light Diagnostics ™ Coxsackievirus B3 Monoclonal Antibody
Company
EMD Millipore Corporation
Model
3306
Catalog number
3306
Device description
Coxsackievirus B3 Monoclonal Antibody
Published
2022-11-29
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
GNMAntisera, Fluorescent, Coxsackievirus A 1-24, B 1-6

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNMAntisera, Fluorescent, Coxsackievirus A 1-24, B 1-6Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K936251000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K936251000COXSACKIEVIRUS B3 MONOCLONAL ANTIBODYLight Diagnostics1995-09-08GNM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053252404719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053252404719040532524047194053252404719

GMDN Terms#

Term, Definition table
TermDefinition
Coxsackie A/B 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 multiple Coxsackie virus antigens from group A and B in a clinical specimen.

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
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
04049016060994IFA Mosaic: Coxsackie virus (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNM2022-12-08
04049016061151IFA Mosaic: Coxsackie virus A Types (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNM2022-12-08
04049016061175IFA Mosaic: Coxsackie virus A Types (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNM2022-12-08
04049016061311IFA Mosaic: Coxsackie virus B Types (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNM2022-12-08
04049016061335IFA Mosaic: Coxsackie virus B Types (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNM2022-12-08
04049016061472IFA Mosaic: Coxsackie virus Type A7 / Type B1 (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNM2022-12-08
04049016061489IFA Mosaic: Coxsackie virus Type A7 / Type B1 (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNM2022-12-08
04049016080787IFA Mosaic: Coxsackie virus A Types (IgG)EUROIMMUN Medizinische Labordiagnostika AGGNM2022-12-08
04061841171218Light Diagnostics ™ Coxsackie B Control SlideEMD Millipore CorporationGNM2022-12-01
04061841171737Light Diagnostics ™ Coxsackie A9/A24 Control SlideEMD Millipore CorporationGNM2022-12-01
04053252404290Light Diagnostics ™ Coxsackievirus A Control SlidesEMD Millipore CorporationGNM2022-11-30
04053252729225Light Diagnostics ™ Coxsackievirus B Control Slides EMD Millipore CorporationGNM2022-11-30
04053252326011Light Diagnostics™ Coxsackievirus A24 Monoclonal AntibodyEMD Millipore CorporationGNM2022-11-29
04053252326264Light Diagnostics ™ Coxsackievirus B1 Monoclonal AntibodyEMD Millipore CorporationGNM2022-11-29
04053252332371Light Diagnostics ™ Coxsackievirus B5 Monoclonal AntibodyEMD Millipore CorporationGNM2022-11-29
04053252408489Light Diagnostics ™ Coxsackievirus B4 Monoclonal AntibodyEMD Millipore CorporationGNM2022-11-29
04053252516092Light Diagnostics ™ Coxsackievirus B2 Monoclonal AntibodyEMD Millipore CorporationGNM2022-11-29
04053252585258Light Diagnostics ™ Coxsackie Antibody SetEMD Millipore CorporationGNM2022-11-29
04053252672989Light Diagnostics™ Coxsackievirus A9 Monoclonal AntibodyEMD Millipore CorporationGNM2022-11-29
04053252734557Light Diagnostics ™ Coxsackievirus B Blend Monoclonal AntibodiesEMD Millipore CorporationGNM2022-11-29
04053252472985Light Diagnostics ™ Coxsackievirus B6 Monoclonal AntibodyEMD Millipore CorporationGNM2022-09-24