FDA Registration
Active
🇺🇸 United States
DxNow Inc.
Reg #: 3014527900
·
FEI: 3014527900
·
Expires 2026
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DxNow Inc.
- Registration Number
- 3014527900
- FEI Number
- 3014527900
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 401 Professional Drive, Suite 130
- City
- Gaithersburg
- State
- MD
- ZIP
- 20879
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173075
Owner / Operator
- Firm Name
- DxNow, Inc.
- Operator Number
- 10057557
- Address
- 401 Professional Drive, Suite 130
- City
- Gaithersburg
- State
- MD
- Postal Code
- 20879
- Country
- US
- Correspondent
- Brian Szeremeta
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2018-04-24 |
Proprietary Names
ZyMot Multi Sperm Separation Device
ZyMot ICSI Sperm Separation Device
Establishment Types
Repack or Relabel Medical Device