FDA Registration
Active
🇺🇸 United States
SPOT HEALTH INC.
Reg #: 3026940910
·
FEI: 3026940910
·
Expires 2026
Products
9
Proprietary Names
1
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- SPOT HEALTH INC.
- Registration Number
- 3026940910
- FEI Number
- 3026940910
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1776 Mentor Ave.
- City
- Cincinnati
- State
- OH
- ZIP
- 45212
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223243
Owner / Operator
- Firm Name
- Spot Health Inc.
- Operator Number
- 10089149
- Address
- 1776 Mentor Ave.
- City
- Cincinnati
- State
- OH
- Postal Code
- 45212
- Country
- US
- Correspondent
- Andrew Jajack
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | Class 2 | Clinical Chemistry | No | 2023-11-09 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2023-11-09 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2023-11-09 |
| Dna Probe, Nucleic Acid Amplification, Chlamydia | MKZ | Class 1 | Microbiology | No | 2023-11-09 |
| Dna-Reagents, Neisseria | LSL | Class 2 | Microbiology | No | 2023-11-09 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2023-11-09 |
| Blood And Urine Collection Kit (Excludes Hiv Testing) | OIB | Class 1 | Pathology | No | 2023-11-09 |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | Class 1 | Pathology | No | 2026-04-21 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2023-11-09 |
Proprietary Names
Verisana Urine Sample Collection Kit
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device