MedtechSourcebook

NEW LIFE DIAGNOSTICS INC.

Contract manufacturer · Carlsbad, CA

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
3011527950 (openFDA record; or search FDA's registration database)
FEI number
3011527950
Registered for
FDA registration year 2026
Establishment types
Manufacturer for export only; Manufacturer; Contract manufacturer
Owner or operator
New Life Diagnostics. Inc. (FDA owner/operator no. 10048943)
Registered address
5909 Sea Lion Pl, Suite A, Carlsbad, CA 92010
Contract listings
7 device listings, 7 product codes, first listed Mar 23, 2015
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
GNHAntigen, Fluorescent Antibody Test, Schistosoma MansoniClass IMicrobiologyContract manufacturingMar 23, 2015
GPFAntigen, Agglutinating, Echinococcus Spp.Class IMicrobiologyContract manufacturingMar 23, 2015
GRXAntisera, All Leptospira Spp.Class IIMicrobiologyContract manufacturingFeb 1, 2018
KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.Class IIMicrobiologyContract manufacturingMar 23, 2015
LOOReagent, Leishmanii SerologicalClass IMicrobiologyContract manufacturingMar 24, 2020
MDJReagents, CysticercosisClass IMicrobiologyContract manufacturingMar 23, 2015
MDTElisa, Trichinella SpiralisClass IMicrobiologyContract manufacturingMar 23, 2015