FDA Registration
Active
🇺🇸 United States
VMRD, Inc.
Reg #: 3004036192
·
FEI: 3004036192
·
Expires 2026
Products
10
Proprietary Names
10
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- VMRD, Inc.
- Registration Number
- 3004036192
- FEI Number
- 3004036192
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1312 E Valencia Dr
- City
- FULLERTON
- State
- CA
- ZIP
- 92831
- Country
- US
Regulatory Submissions
- 510(k) Number
- K925690
Owner / Operator
- Firm Name
- VMRD, Inc.
- Operator Number
- 10092390
- Address
- 1312 E. Valencia Dr.
- City
- Fullerton
- State
- CA
- Postal Code
- 92831
- Country
- US
- Correspondent
- Ethan Adams
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orientia Spp. (Scrub Typhus) Serological Reagents | QIQ | Class N | Unknown | No | 2024-12-31 |
| Reagent, Rickettsia Serological | LSQ | Class 1 | Microbiology | No | 2024-12-31 |
| Babesia Spp. Serological Reagents | QIN | Class N | Unknown | No | 2024-12-31 |
| Test, Antigen, Nuclear, Epstein-Barr Virus | LLM | Class 1 | Microbiology | No | 2024-12-31 |
| Bartonella Spp. Serological Reagents | QIM | Class N | Unknown | No | 2024-12-31 |
| Immunofluorescent Assay, T. Cruzi | MIV | Class 1 | Microbiology | No | 2024-12-31 |
| Antigen, Cf, Q Fever | GPS | Class 1 | Microbiology | No | 2024-12-31 |
| Anaplasma Spp. And Ehrlichia Spp. Serological Reagents | QIO | Class N | Unknown | No | 2024-12-31 |
| Antigens, Slide And Tube, Francisella Tularensis | GSL | Class 2 | Microbiology | No | 2024-12-31 |
| Antigens, All, Leptospira Spp. | GRY | Class 2 | Microbiology | No | 2024-12-31 |
Proprietary Names
Orientia Spp. (Scrub Typhus) Serological Reagents - Orientia IgG MIF Assay; Orientia IgM MIF Assay
Reagent, Rickettsia Serological - Rickettsia IgM ELISA Assay; Rickettsia typhi IgG ELISA; Rickettsia typhi IgM ELISA; SF
Babesia Spp. Serological Reagents - Babesia IFA
Test, Antigen, Nuclear, Epstein-Barr Virus - EBNA ACIF Slide
Bartonella Spp. Serological Reagents - Bartonella IFA
Immunofluorescent Assay, T. Cruzi - Trypanosoma IFA
Antigen, Cf, Q Fever - Coxiella Burnetii MIF
Anaplasma Spp. and Ehrlichia Spp. Serological Reagents - Anaplasma / Ehrlichia IFA
Antigens, Slide and Tube, Francisella Tularensis - Francisella Tularensis IFA
Antigens, All, Leptospira Spp. - Leptospira IFA
Establishment Types
Manufacture Device in the United States for Export Only
Manufacture Medical Device