FDA Registration
Active
🇺🇸 United States
ACCU NEWS Ovulation Test + Pregnancy Test Combo
Reg #: 3031823359
·
FEI: 3031823359
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CorDx, Inc.
- Registration Number
- 3031823359
- FEI Number
- 3031823359
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5900 Windward Pkwy
- City
- Alpharetta
- State
- GA
- ZIP
- 30005
- Country
- US
Owner / Operator
- Firm Name
- CorDx
- Operator Number
- 10050914
- Address
- 9540 Waples St Unit C
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Amber Wen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2016-01-15 |
Proprietary Names
ACCU NEWS Ovulation Test + Pregnancy Test Combo
CorDx Tyfast Ovulation Test Cassette
CorDx Tyfast Ovulation Test Strip + Pregnancy Test Strip
CorDx Tyfast Ovulation Test Midstream
CorDx Tyfast Ovulation Test Strip
Establishment Types
Manufacture Medical Device