FDA Registration
Active
🇺🇸 United States
CareStart COVID-19 Antigen Home Test
Reg #: 3024756665
·
FEI: 3024756665
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Access Bio, Inc.
- Registration Number
- 3024756665
- FEI Number
- 3024756665
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7 Fitzgerald Ave
- City
- Monroe Township
- State
- NJ
- ZIP
- 08831
- Country
- US
Owner / Operator
- Firm Name
- ACCESS BIO INCORPORATE
- Operator Number
- 10028116
- Address
- 65 Clyde Rd. Suite A
- City
- Somerset
- State
- NJ
- Postal Code
- 08873
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2020-10-09 |
Proprietary Names
CareStart COVID-19 Antigen Home Test
CareStart COVID-19 Antigen
on/go COVID-19 Antigen SelfTest
Establishment Types
Manufacture Medical Device