FDA Registration
Active
🇺🇸 United States
WAVESENSE, INC.
Reg #: 3005592623
·
FEI: 3005592623
·
Expires 2026
Products
10
Proprietary Names
25
Establishment Types
1
Classifications
10
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Registration Details
- Registration Name
- WAVESENSE, INC.
- Registration Number
- 3005592623
- FEI Number
- 3005592623
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| Solution, Isotonic | JCE | Class 1 | Pathology | No | 2012-08-01 |
| Immunohistochemistry Reagents And Kits | NJT | Class 1 | Hematology | No | 2012-08-01 |
| Detergent | JCB | Class 1 | Pathology | No | 2012-08-01 |
| Micro Mixer | JRB | Class 1 | Clinical Chemistry | No | 2014-09-17 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2012-08-01 |
| Filters, Cell Collection, Tissue Processing | KET | Class 1 | Pathology | No | 2010-12-30 |
| Stains, Hematology | KQC | Class 1 | Hematology | No | 2012-08-07 |
| Blender/Mixer | JRO | Class 1 | Clinical Chemistry | No | 2012-08-01 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2019-09-11 |
| Shaker/Stirrer | JRQ | Class 1 | Clinical Chemistry | No | 2012-08-01 |
Proprietary Names
Blocking Buffer
Anti-CD138 (B-A38) Antibody, paramagnetic
Anti-URO-1 (J143)
Anti-Urothelial (LBS8) Antibody, paramagnetic
Anti-URO-1 (P1B5) Antibody, paramagnetic
Anti-EpCAM (323/A3) Antibody, paramagnetic
Debulking Buffer
Revolution Sample Prep System
Revolution System
EpiSep NSD II (Neo-Magnetic Slide Dock)
EpiSep NSD I (Neo-Magnetic Slide Dock)
15 mL Magnetic Tube Dock
5 mL Magnetic Tube Dock
2 mL Magnetic Tube Dock
50 mL Magnetic Tube Dock
EpiSep MSD5 (Five Position Magnetic Slide Dock)
EpiSep HS (Hybridization Slide)
CellCycler
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
50 mL Tube Mixer
Establishment Types
Manufacture Medical Device