FDA Registration
Active
🇺🇸 United States
SALADAX BIOMEDICAL, INC.
Reg #: 3005567065
·
FEI: 3005567065
·
Expires 2026
Products
5
Proprietary Names
17
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- SALADAX BIOMEDICAL, INC.
- Registration Number
- 3005567065
- FEI Number
- 3005567065
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 116 RESEARCH DR.
- City
- BETHLEHEM
- State
- PA
- ZIP
- 18015
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN190028
Owner / Operator
- Firm Name
- SALADAX BIOMEDICAL, INC.
- Operator Number
- 9097239
- Address
- 116 RESEARCH DR., --
- City
- Bethlehem
- State
- PA
- Postal Code
- 18015
- Country
- US
- Correspondent
- Salvatore Salamone, PhD
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clozapine Test System | QKT | Class 2 | Clinical Chemistry | No | 2020-04-17 |
| Docetaxel / Paclitaxel Assay | PRF | Class N | Unknown | No | 2018-10-19 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2011-08-19 |
| Drug Specific Control Materials | LAS | Class 1 | Clinical Toxicology | No | 2020-04-17 |
| 5-Fluorouracil Assay | OXR | Class N | Unknown | No | 2011-08-25 |
Proprietary Names
MyCare Psychiatry Clozapine Assay Kit
MyDocetaxel Assay Kit
MyPaclitaxel Assay Kit
MyImatinib Calibrator Kit
MyCare Psychiatry Calibrator Kit 2
MyCare Psychiatry Calibrator Kit 1
My5-FU Calibrator Kit
MyDocetaxel Calibrator Kit
MyPaclitaxel Calibrator Kit
MyCare Psychiatry Control Kit 2
My5-FU Sample Stabilizer
My5-FU Assay
MyImatinib Control Kit
MyCare Psychiatry Control Kit 1
My5-FU Control Kit
MyPaclitaxel Control Kit
MyDocetaxel Control Kit
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only