FDA Registration
Active
🇺🇸 United States
NEW LIFE DIAGNOSTICS INC.
Reg #: 3011527950
·
FEI: 3011527950
·
Expires 2026
Products
8
Proprietary Names
20
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- NEW LIFE DIAGNOSTICS INC.
- Registration Number
- 3011527950
- FEI Number
- 3011527950
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5909 Sea Lion Pl, Suite A
- City
- Carlsbad
- State
- CA
- ZIP
- 92010
- Country
- US
Owner / Operator
- Firm Name
- New Life Diagnostics. Inc.
- Operator Number
- 10048943
- Address
- 5909 Sea Lion Place, Suite A
- City
- Carlsbad
- State
- CA
- Postal Code
- 92010
- Country
- US
- Correspondent
- Michelle Y Larmour
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antisera, All Leptospira Spp. | GRX | Class 2 | Microbiology | No | 2018-02-01 |
| Reagents, Cysticercosis | MDJ | Class 1 | Microbiology | No | 2015-03-23 |
| Antigen, Agglutinating, Echinococcus Spp. | GPF | Class 1 | Microbiology | No | 2015-03-23 |
| Device, General Purpose, Microbiology, Diagnostic | LIB | Class 1 | Microbiology | No | 2026-05-22 |
| Reagent, Leishmanii Serological | LOO | Class 1 | Microbiology | No | 2020-03-24 |
| Elisa, Trichinella Spiralis | MDT | Class 1 | Microbiology | No | 2015-03-23 |
| Antigen, Fluorescent Antibody Test, Schistosoma Mansoni | GNH | Class 1 | Microbiology | No | 2015-03-23 |
| Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | KHW | Class 2 | Microbiology | No | 2015-03-23 |
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
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Manufacture Device in the United States for Export Only