FDA Registration
Active
🇺🇸 United States
Revolution cfDNA Max 20 Kit
Reg #: 3005592623
·
FEI: 3005592623
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- WAVESENSE, INC.
- Registration Number
- 3005592623
- FEI Number
- 3005592623
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15339 Barranca Pkwy
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Owner / Operator
- Firm Name
- WaveSense, Inc. dba nRichDX
- Operator Number
- 10034778
- Address
- 15339 Barranca Parkway
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- William W Curtis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2019-09-11 |
Proprietary Names
Revolution cfDNA Max 20 Kit
Revolution cfDNA Reagent Kit
Revolution cfDNA Max 20XL Kit
Revolution cfTNA Max 20 Kit
Revolution cfTNA Reagent Kit
Revolution cfTNA Max 20XL Kit
Establishment Types
Manufacture Medical Device