FDA.reportPublic FDA data

Light Diagnostics™ Influenza A and B DFA Kit

Primary DI
08436037124594
Brand
Light Diagnostics™ Influenza A and B DFA Kit
Company
EMD Millipore Corporation
Model
3123
Catalog number
3123
Device description
Influenza A and B DFA Kit
Published
2022-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GNWAntisera, Cf, Influenza Virus A, B, C

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNWAntisera, Cf, Influenza Virus A, B, CMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436037124594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436037124594084360371245948436037124594

GMDN Terms#

Term, Definition table
TermDefinition
Influenza/parainfluenza virus antigen IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from influenza and parainfluenza viruses [e.g., influenza A, influenza B, human parainfluenza virus 1 (HPIV-1), human parainfluenza virus 2 (HPIV-2)] in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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04053252471827Light Diagnostics ™ Pan-Enterovirus Reagent 3360-10ML3360-10ML2022-12-05
04061841171201Light Diagnostics ™ Poliovirus Control Slide50206502062022-12-05
04061841171225Light Diagnostics ™ Echovirus Control Slide50207502072022-12-05
04061841171478Light Diagnostics ™ Enterovirus70/71 Control Slide50266502662022-12-05
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
04053252357497Light Diagnostics™Mouse Anti-Rabies Monoclonal Antibody; Clone Name C18-62-143-2MAB8724MAB87242022-12-01
04053252360862Light Diagnostics ™ Mouse Anti-Cytomegalovirus Monoclonal AntibodyMAB810-500UGMAB810-500UG2022-12-01
04053252364068Light Diagnostics ™ Mumps Control Slides5029-55029-52022-12-01
04053252373435Light Diagnostics ™ Influenza A & B Control Slides5010-55010-52022-12-01
04053252399756Light Diagnostics™ Mouse Anti-Rabies Monoclonal Antibody; Clone Name C10-62-52-2MAB8722MAB87222022-12-01
04053252403323Light Diagnostics ™ Measles Control Slides5031-55031-52022-12-01
04053252473166Light Diagnostics ™ SimulFluor® Respiratory Screen Kit3296-2ML3296-2ML2022-12-01
04053252505522Light Diagnostics™ Mouse Anti-Rabies Monoclonal Antibody; Clone Name C15-62-97-3MAB8723MAB87232022-12-01
04053252507007Light Diagnostics ™ Respiratory Screen DFA Reagent5307-2ML5307-2ML2022-12-01
04053252508295Light Diagnostics ™ Adenovirus Control Slides5009-55009-52022-12-01
04053252576775Light Diagnostics ™ Mouse Anti-Rabies Monoclonal Antibody; Clone Name C2-62-8-2MAB8719MAB87192022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ENTIINFG02900NovaLisa Influenza Virus A IgGGold Standard Diagnostics Frankfurt GmbHGNW2024-08-26
ENTIINFG03000NovaLisa Influenza Virus B IgGGold Standard Diagnostics Frankfurt GmbHGNW2024-08-26
ENTIINFG0290NovaLisa Influenza Virus A IgGGold Standard Diagnostics Frankfurt GmbHGNW2024-08-26
ENTIINFG0300NovaLisa Influenza Virus B IgGGold Standard Diagnostics Frankfurt GmbHGNW2024-08-26
05032384503070IMAGEN RESPIRATORY SCREEN POS CON SLIDEOXOID LIMITEDGNW2024-07-03
04048474037937Influenza Virus A IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungGNW2023-08-31
04048474037968Influenza Virus B IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGNW2023-08-31
00840239037930Influenza Virus A IgG ELISA DRG International IncGNW2023-08-25
00840239037961Influenza Virus B IgG ELISADRG International IncGNW2023-08-25
B350GSD0130090Influenza A IgG ELISA Test KitGold Standard Diagnostics CorporationGNW2022-12-07
04053252270239Light Diagnostics ™ SimulFluor® Flu A / Flu B ReagentEMD Millipore CorporationGNW2022-12-01
04053252373435Light Diagnostics ™ Influenza A & B Control SlidesEMD Millipore CorporationGNW2022-12-01
04053252320439Light Diagnostics ™ Influenza A FITC-Labeled Monoclonal AntibodyEMD Millipore CorporationGNW2022-11-30
04053252368165Light Diagnostics ™ SimulFluor® Flu A/Flu B ReagentEMD Millipore CorporationGNW2022-11-30
04053252473722Light Diagnostics ™ Influenza B Monoclonal AntibodyEMD Millipore CorporationGNW2022-11-30
04053252789229Light Diagnostics ™ Influenza A & B Control SlideEMD Millipore CorporationGNW2022-11-30
04053252330094Light Diagnostics ™ Influenza B Monoclonal AntibodyEMD Millipore CorporationGNW2022-11-29
04053252470226Light Diagnostics ™ Influenza A Monoclonal AntibodyEMD Millipore CorporationGNW2022-11-29
04053252367588Light Diagnostics™ SimulFluor® Flu A/Flu B Immunofluorescence AssayEMD Millipore CorporationGNW2022-11-28
B350GSD0130100Influenza B IgG ELISA Test KitGold Standard Diagnostics CorporationGNW2022-10-07
00404847437935Influenza Virus A IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGNW2021-06-07
00404847437966Influenza Virus B IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGNW2021-06-07
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30014613330349D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
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