FDA Registration
Active
🇺🇸 United States
MyImatinib Calibrator Kit
Reg #: 3005567065
·
FEI: 3005567065
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SALADAX BIOMEDICAL, INC.
- Registration Number
- 3005567065
- FEI Number
- 3005567065
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 116 RESEARCH DR.
- City
- BETHLEHEM
- State
- PA
- ZIP
- 18015
- Country
- US
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 |
|---|---|---|---|---|---|
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2011-08-19 |
Proprietary Names
MyImatinib Calibrator Kit
MyCare Psychiatry Calibrator Kit 1
MyCare Psychiatry Calibrator Kit 2
MyDocetaxel Calibrator Kit
MyPaclitaxel Calibrator Kit
My5-FU Calibrator Kit
Establishment Types
Manufacture Device in the United States for Export Only