FDA.reportPublic FDA data

New Life Diagnostics

Primary DI
00850078606181
Brand
New Life Diagnostics
Company
NEW LIFE DIAGNOSTICS LLC
Model
Gnathostoma IgG ELISA Kit
Catalog number
5040
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
00850078606181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078606181008500786061818500786061810850078606181

GMDN Terms#

Term, Definition table
TermDefinition
Assay development analyte-specific reagent IVDAn antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.

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
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
00850078606327New Life DiagnosticsParagonimus IgG ELISA Kit50292026-04-16