FDA.reportPublic FDA data

West Nile Virus IgM Capture DxSelect™

Primary DI
20816101022025
Brand
West Nile Virus IgM Capture DxSelect™
Company
DIASORIN MOLECULAR LLC
Model
EL0300M
Catalog number
EL0300M
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NOPElisa, Antibody, West Nile Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOPElisa, Antibody, West Nile VirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040854000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040854000WEST NILE VIRUS IGM CAPTURE ELISAFocus Technologies, Inc.2004-06-30NOP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816101022025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081610102202520816101022025

GMDN Terms#

Term, Definition table
TermDefinition
West Nile virus immunoglobulin M (IgM) antibody 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 immunoglobulin M (IgM) antibodies to West Nile virus 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
562-240-6500DxTs@focusdx.com
562-240-6500TS.Molecular@DiaSorin.com

Regulatory Flags#

DUNS number
080271715
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20816101020243Rickettsia IFA IgGIF0100GIF0100G2026-03-13
20816101020250Rickettsia IFA IgMIF0100MIF0100M2026-03-13
20816101020342Q Fever IFA IgGIF0200GIF0200G2026-03-13
20816101020359Q Fever IFA IgMIF0200MIF0200M2026-03-13
20816101020397Arbovirus IFA IgGIF0300GIF0300G2026-03-13
20816101020403Arbovirus IFA IgMIF0300MIF0300M2026-03-13
20816101025538Simplexa™ Flu A/B & RSVMOL2600MOL26002016-09-22
20816101025507Simplexa™ HSV 1 & 2 DirectMOL2150MOL21502016-09-22
20816101025514Simplexa™ HSV 1 & 2 Positive Control PackMOL2160MOL21602016-09-22
10816101025142LIAISON NES® InstrumentNES1001NES10012026-01-22
10816101025159LIAISON NES® Instrument (Refurbished)NES1001RNES1001R2026-01-22
20816101029031LIAISON NES® FLU A/B, RSV & COVID-19NES4450NES44502026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitNES4460NES44602026-01-22
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectMOL4450MOL44502026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackMOL4460MOL44602026-01-14
10816101020772R. rickettsii Substrate SlideIF0102IF01022025-12-16
10816101027375Blastomyces Primer PairMOL9206MOL92062025-12-16
20816101027136Simplexa COVID-19 Positive Control GEN II Pack MOL4165MOL41652025-09-17
10816101025005Integrated Cyler (110V)MOL1001MOL10012016-09-24
10816101025012Integrated Cyler (110V) Pre-OwnedMOL1001-PMOL1001-P2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10816101022325West Nile Virus IgG DxSelect™ IgG Cutoff CalibratorDIASORIN MOLECULAR LLCNOP2017-07-11
10816101022332West Nile Virus IgG Positive Control DxSelect™ - IgG Positive ControlDIASORIN MOLECULAR LLCNOP2017-07-11
10816101022349West Nile Virus IgG DxSelect™ - IgG Antigen WellsDIASORIN MOLECULAR LLCNOP2017-07-11
10816101022318West Nile Virus IgG DxSelect™ - IgG ConjugateDIASORIN MOLECULAR LLCNOP2017-07-11
10816101022271West Nile Virus IgM Capture DxSelect™ Anti-Flavivirus ConjugateDIASORIN MOLECULAR LLCNOP2017-05-16
10816101022288West Nile Virus IgM Capture DxSelect™ IgM Cutoff Calibrator (0.3 mL)DIASORIN MOLECULAR LLCNOP2017-05-16
B379WNMS11 West Nile Detect IgM Capture ELISAINBIOS INTERNATIONAL, INCNOP2016-11-21
04049016028178Anti-West Nile Virus ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGNOP2016-09-24
04049016028185Anti-West Nile Virus ELISA (IgM)EUROIMMUN Medizinische Labordiagnostika AGNOP2016-09-24
10816101022219IgM Capture WellsDIASORIN MOLECULAR LLCNOP2016-09-22
10816101022042West Nile Virus DxSelect™ Negative ControlDIASORIN MOLECULAR LLCNOP2016-09-22
10816101022059West Nile Virus IgM Capture DxSelect™ Positive ControlDIASORIN MOLECULAR LLCNOP2016-09-22
10816101022066West Nile Virus IgM Capture DxSelect™ AntigenDIASORIN MOLECULAR LLCNOP2016-09-22
20816101022001West Nile Virus IgG DxSelect™DIASORIN MOLECULAR LLCNOP2016-09-22
20816101022018West Nile Virus IgG DxSelect™DIASORIN MOLECULAR LLCNOP2016-09-22
20816101022032West Nile Virus IgM Capture DxSelect™DIASORIN MOLECULAR LLCNOP2016-09-22