FDA Registration
Active
🇺🇸 United States
IVD RESEARCH, LLC.
Reg #: 2031468
·
FEI: 3002023342
·
Expires 2026
Products
10
Proprietary Names
9
Establishment Types
3
Classifications
10
Registration Details
- Registration Name
- IVD RESEARCH, LLC.
- Registration Number
- 2031468
- FEI Number
- 3002023342
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5909 SEA LION PLACE, SUITE D
- City
- Carlsbad
- State
- CA
- ZIP
- 92010
- Country
- US
Owner / Operator
- Firm Name
- IVD RESEARCH, LLC.
- Operator Number
- 9034173
- Address
- 5909 SEA LION PLACE, SUITE D, --
- City
- Carlsbad
- State
- CA
- Postal Code
- 92010
- Country
- US
- Correspondent
- Chris Lambillotte
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp | GWD | Class 2 | Microbiology | No | 1998-06-16 |
| Giardia Spp. | MHI | Class 2 | Microbiology | No | 2001-06-13 |
| Antigen, Fluorescent Antibody Test, Schistosoma Mansoni | GNH | Class 1 | Microbiology | No | 2003-09-17 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2021-07-07 |
| Cryptosporidium Spp. | MHJ | Class 2 | Microbiology | No | 2001-06-13 |
| Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp. | GMO | Class 2 | Microbiology | No | 1998-07-16 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-09-22 |
| Immunoassay, Pregnanediol Glucuronide, Over The Counter | QKE | Class 1 | Clinical Chemistry | No | 2020-03-16 |
| Elisa, Trichinella Spiralis | MDT | Class 1 | Microbiology | No | 1998-06-16 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2020-07-30 |
Proprietary Names
INDIRECT FLUORESCENT ANTIBODY TEST
, ENTAMOEBA HISTOLYTICA
REL SP
Giardia/Cryptosporidium Combo Stool Antigen Detection ELISA
GIARDIA STOOL ANTIGEN ELISA
IVD Research Schistosoma ELISA Test Kit
Cryptosporidium Antigen Detection ELISA
E. histolytica/Dispar Antigen Detei
IVD Research Trichinella ELISA Test Kit
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)