FDA.reportPublic FDA data

West Nile Detect IgM Capture ELISA

Primary DI
B379WNMS11
Brand
West Nile Detect IgM Capture ELISA
Company
INBIOS INTERNATIONAL, INC
Model
WNMS1
Catalog number
WNMS-1
Published
2016-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B379WNMS11PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004006628
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B379COVGRE1SCoV-2 Detect™ IgG Rapid TestCOVG-RE2022-12-08
B379RCFP251COVID/Flu A&B RespiraDXTM Rapid TestRCFP-25RCFP-252025-10-06
B379RCFPCK101COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (10 sets)RCFP-CK102025-10-06
B379RCFPCK21COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (1 set)RCFP-CK22025-10-06
B379RCFS21COVID/Flu A&B RespiraDXTM Rapid Self-TestRCFS-2RCFS-22025-10-06
B379RCFS41COVID/Flu A&B RespiraDXTM Rapid Self-TestRCFS-4RCFS-42025-10-06
B379COV2E0Smart DetectTM SARS-CoV-2 rRT-PCR KitCOV2-E2020-07-15
B379COVAF201SCoV-2 Ag Detect™ Rapid TestCOVAF-202024-09-13
B379COVAF501SCoV-2 Ag Detect™ Rapid TestCOVAF-502024-09-13
B379STNG11Strongy DetectTM IgG ELISASTNG-12024-09-13
B379ZKM21ZIKV Detect™ 2.0 IgM Capture ELISAIVD2019-05-24
B379COVNE1SCoV-2 Detect™ Neutralizing Ab ELISACOVN-E2022-12-08
B379C19S21COVID-19 Detect™ Rapid Self -TestC19S-22026-01-16
B379RCFPCK201COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (20 sets)RCFP-CK202025-10-06
B379AAP11Active Anthrax Detect Plus Rapid TestAAP-12023-03-03
B379CAGS21SCoV-2 Ag Detect™ Rapid Self-TestCAGS-22022-12-08
B379COVAGRC1SCoV-2 Ag Detect™ Rapid TestCOVAG-RC2022-12-08
B379COVEG1SCoV-2 Detect™ IgG ELISACOVE-G2022-12-08
B379COVEM1SCoV-2 Detect™ IgM ELISACOVE-M2022-12-08
B379CL0251CL Detect Rapid Test for Cutaneous LeishmaniasisCL025CL0252018-09-24

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
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
20816101022025West Nile Virus IgM Capture DxSelect™DIASORIN MOLECULAR LLCNOP2016-09-22
20816101022032West Nile Virus IgM Capture DxSelect™DIASORIN MOLECULAR LLCNOP2016-09-22