FDA Registration
Active
🇺🇸 United States
Histoplasma urine antigen control kit
Reg #: 3005369540
·
FEI: 3005369540
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MIRAVISTA DIAGNOSTICS
- Registration Number
- 3005369540
- FEI Number
- 3005369540
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4705 Decatur Boulevard
- City
- Indianapolis
- State
- IN
- ZIP
- 46241
- Country
- US
Owner / Operator
- Firm Name
- MiraVista Diagnostics
- Operator Number
- 10077725
- Address
- 4705 Decatur Boulevard
- City
- Indianapolis
- State
- IN
- Postal Code
- 46241
- Country
- US
- Correspondent
- Heather Largura
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum | MIZ | Class 2 | Microbiology | No | 2020-09-15 |
Proprietary Names
Histoplasma urine antigen control kit
Histoplasma urine antigen LFA test kit
Establishment Types
Manufacture Device in the United States for Export Only