FDA Registration
Active
🇺🇸 United States
501-204 CDS Rinse Solution
Reg #: 1064130
·
FEI: 3002684533
·
Expires 2025
Products
1
Proprietary Names
15
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CLINICAL DIAGNOSTIC SOLUTIONS, INC.
- Registration Number
- 1064130
- FEI Number
- 3002684533
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1800 N.W. 65TH AVE.
- City
- PLANTATION
- State
- FL
- ZIP
- 33313
- Country
- US
Owner / Operator
- Firm Name
- Boule Diagnostics AB
- Operator Number
- 9034165
- Address
- Domnarvsgatan 4
- City
- Spanga
- State
- SE-NOTA
- Postal Code
- SE-163 53
- Country
- SE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Detergent | JCB | Class 1 | Pathology | No | 2015-11-17 |
Proprietary Names
501-204 CDS Rinse Solution
501-205 CDS Rinse Solution
501-066 CDS DETERGENT REAGENT
501-350 Quintus 5-Part Stopper
501-073 CDS DETERGENT REAGENT
501-032 ENZYMATIC CLEANER
501-036 Boule Cleaning Kit
501-002 ENZYMATIC CLEANER
501-029 Ac.T Cleaner and Shutdown Solution
501-477 Quintus 5-Part Stopper
501-074 Enzymatic Cleaner Concentrate
Cell-Dyn Emerald Cleaner
Boule EasyCleaner
501-064 CDS DETERGENT REAGENT
501-063 ENZYMATIC CLEANER CONCENTRATE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device