NEW LIFE DIAGNOSTICS INC.

FDA Device Registration & Listing · Carlsbad, CA, US · Registration 3011527950

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011527950
FEI Number
3011527950
Entity Name
NEW LIFE DIAGNOSTICS INC.
City/State/Country
Carlsbad, CA, US
Establishment Address
5909 Sea Lion Pl, Suite A, Carlsbad, CA 92010, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
New Life Diagnostics. Inc. (Owner Number: 10048943)
Owner / Operator Contact Address
5909 Sea Lion Place, Suite A, Carlsbad, CA 92010, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

New Life Diagnostics Leptospira ELISA New Life Diagnostics Cysticercosis ELISA New Life Diagnostics Echinococcus ELISA Spirometra ELISA assay Kit Opisthorchis ELISA assay Kit Leishmania Serum ELISA Test Kit New Life Diagnostics Fasciola gigantica ELISA New Life Diagnostics Trichinella ELISA New Life Diagnostics Ascaris ELISA New Life Diagnostics Strongyloides ELISA New Life Diagnostics Filariasis ELISA New Life Diagnostics Anclyostoma ELISA New Life Diagnostics Toxocara ELISA New Life Diagnostics Angiostrongylus ELISA New Life Diagnostics Gnathostoma ELISA New Life Diagnostics Fasciola ELISA New Life Diagnostics Schistosoma ELISA New Life Diagnostics Clonorchis ELISA New Life Diagnostics Paragonimus ELISA New Life Diagnostics E. histolytica ELISA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GRX Antisera, All Leptospira Spp. Microbiology Class 2 866.3350 2018-02-01
MDJ Reagents, Cysticercosis Microbiology Class 1 866.3200 2015-03-23
GPF Antigen, Agglutinating, Echinococcus Spp. Microbiology Class 1 866.3200 2015-03-23
LIB Device, General Purpose, Microbiology, Diagnostic Microbiology Class 1 866.2660 2026-05-22
LOO Reagent, Leishmanii Serological Microbiology Class 1 866.3870 2020-03-24
MDT Elisa, Trichinella Spiralis Microbiology Class 1 866.3850 2015-03-23
GNH Antigen, Fluorescent Antibody Test, Schistosoma Mansoni Microbiology Class 1 866.3600 2015-03-23
KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. Microbiology Class 2 866.3220 2015-03-23

Official Correspondent

Michelle Larmour

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

New Life Diagnostics. Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011527950. Last updated year: 2026. Please use registration number 3011527950 when referencing this establishment in official correspondence.
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