FDA Registration
Active
🇺🇸 United States
FERTILITY SOLUTIONS, INC.
Reg #: 3003750510
·
FEI: 3003750510
·
Expires 2026
Products
6
Proprietary Names
8
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- FERTILITY SOLUTIONS, INC.
- Registration Number
- 3003750510
- FEI Number
- 3003750510
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4635 Richmond Road, Suite 100
- City
- Warrensville Heights
- State
- OH
- ZIP
- 44128
- Country
- US
Owner / Operator
- Firm Name
- FERTILITY SOLUTIONS,
- Operator Number
- 9032763
- Address
- 4635 Richmond Road, Suite 100
- City
- Warrensville Heights
- State
- OH
- Postal Code
- 44128
- Country
- US
- Correspondent
- Anna Bort
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Quality Control Slides | LJG | Class 1 | Microbiology | No | 2002-05-08 |
| Hemocytometer | GHO | Class 1 | Hematology | No | 2010-10-22 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2002-05-08 |
| Whole Blood Plasma, Antigen, Antiserum, Control | DGQ | Class 1 | Immunology | No | 2002-05-08 |
| Material, Quality Control, Semen Analysis | NRF | Class 2 | Hematology | No | 2021-10-06 |
| Stains, Chemical Solution | LED | Class 1 | Hematology | No | 2002-05-08 |
Proprietary Names
AQC SPERM MORPHOLOGY SMEARS AND AQC
Spermocytometer
SPERM DILUENT (CHLORAMIN-T)
AQC PROFICIENCY CHALLENGE ANTISPERM
ANTIBODY SCREEN AND ANTISPERM ANTI
FSI Post Vasectomy Quality Control
FSI Sperm Count Quality Control
SPERM VIABILITY STAIN
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)