FDA.reportPublic FDA data

Light Diagnostics ™ SimulFluor® Flu A / Flu B Reagent

Primary DI
04053252270239
Brand
Light Diagnostics ™ SimulFluor® Flu A / Flu B Reagent
Company
EMD Millipore Corporation
Model
5250-5ML
Catalog number
5250-5ML
Device description
SimulFluor® Flu A / Flu B Reagent
Published
2022-12-01
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
GNWAntisera, Cf, Influenza Virus A, B, C

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974302000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974302000LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU BLight Diagnostics1998-04-08GNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053252270239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053252270239040532522702394053252270239

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
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
04053252368165Light Diagnostics ™ SimulFluor® Flu A/Flu B Reagent525052502022-11-30

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
05032384503841IMAGEN Respiratory Screen KitOXOID LIMITEDGNW2024-06-19
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
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
08436037124594Light Diagnostics™ Influenza A and B DFA KitEMD 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
30014613330288D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
30014613330295D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
30014613330301D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
30014613330318D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
30014613330325D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
30014613330349D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07
30014613330356D3 UltraDIAGNOSTIC HYBRIDS, INC.GNW2019-03-07