FDA.reportPublic FDA data

New Life Diagnostics

Primary DI
00850078606365
Brand
New Life Diagnostics
Company
NEW LIFE DIAGNOSTICS LLC
Model
Filariasis IgG ELISA Kit
Catalog number
5035
Published
2026-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850078606365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078606365008500786063658500786063650850078606365

GMDN Terms#

Term, Definition table
TermDefinition
Multiple helminth immunoglobulin G (IgG) antibody IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to multiple helminths (e.g., Opisthorchis felineus, Trichinella spiralis, ¿¿¿¿¿¿r¿ canis, Echinococcus granulosus, Wuchereria bancrofti, Brugia malayi, Onchocerca volvulus) in a clinical specimen.

Regulatory Flags#

DUNS number
081986839
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850078606068New Life DiagnosticsLeishmania IgG ELISA Kit50072026-04-16
00850078606082New Life DiagnosticsLeptospira IgM ELISA Kit50102026-04-16
00850078606136New Life DiagnosticsFasciola gigantica IgG ELISA Kit50152026-04-16
00850078606143New Life DiagnosticsAscaris IgM ELISA Kit50162026-04-16
00850078606150New Life DiagnosticsE. histolytica IgM ELISA Kit50182026-04-16
00850078606167New Life DiagnosticsEchinococcus IgM ELISA Kit50332026-04-16
00850078606174New Life DiagnosticsCysticercosis IgM (T. solium) ELISA Kit50382026-04-16
00850078606181New Life DiagnosticsGnathostoma IgG ELISA Kit50402026-04-16
00850078606198New Life DiagnosticsAngiostrongylus IgM ELISA Kit50302026-04-16
00850078606204New Life DiagnosticsParagonimus IgM ELISA Kit50362026-04-16
00850078606211New Life DiagnosticsClonorchis IgM ELISA Kit50432026-04-16
00850078606235New Life DiagnosticsFasciola IgM ELISA Kit50192026-04-16
00850078606242New Life DiagnosticsLeishmania IgM ELISA Kit50202026-04-16
00850078606259New Life DiagnosticsSchistosoma IgM ELISA Kit50212026-04-16
00850078606266New Life DiagnosticsStrongyloides IgM ELISA Kit50222026-04-16
00850078606273New Life DiagnosticsToxocara IgM ELISA Kit50242026-04-16
00850078606280New Life DiagnosticsTrichinella IgM ELISA Kit50252026-04-16
00850078606297New Life DiagnosticsFasciola gigantica IgM ELISA Kit50262026-04-16
00850078606303New Life DiagnosticsAngiostrongylus IgG ELISA Kit50272026-04-16
00850078606310New Life DiagnosticsClonorchis IgG ELISA Kit50282026-04-16