FDA.report

Light Diagnostics™ SimulFluor® RSV/Para 3 DFA Kit

Primary DI
04053252732294
Brand
Light Diagnostics™ SimulFluor® RSV/Para 3 DFA Kit
Company
EMD Millipore Corporation
Model
3127
Catalog number
3127
Device description
SimulFluor® RSV/Para 3 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

Related Records

Contact Domains

Product Codes

CodeName
LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa

Product Code Classifications

CodeDeviceSpecialtyClass
LKTRespiratory Syncytial Virus, Antigen, Antibody, IfaMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04053252732294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04053252732294040532527322944053252732294

GMDN Terms

TermDefinition
Multiple respiratory virus antigen IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antigens from viruses associated with respiratory diseases in a clinical specimen, using a fluorescent immunoassay method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

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
false
No natural rubber latex
false
Sterilization required before use
false

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Other Devices Sharing Product Codes

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
08436037124624Light Diagnostics™ Respiratory Syncytial Virus DFA KitEMD Millipore CorporationLKT2022-11-28
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