Contract manufacturerCLINICAL DIAGNOSTIC SOLUTIONS, INC. (Plantation, FL)FloridaHematologyPathologyClass IClass II
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Contract manufacturer ยท Plantation, FL
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1064130 (openFDA record; or search FDA's registration database)
- FEI number
- 3002684533
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- Boule Diagnostics AB (FDA owner/operator no. 9034165)
- Registered address
- 1800 N.W. 65TH AVE., Plantation, FL 33313
- Contract listings
- 4 device listings, 4 product codes, first listed Jun 4, 1999
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| GGK | Products, Red-Cell Lysing Products | Class I | Hematology | Contract manufacturing | Jun 4, 1999 |
| GIF | Diluent, Blood Cell | Class I | Hematology | Contract manufacturing | Feb 13, 2013 |
| JCB | Detergent | Class I | Pathology | Contract manufacturing | Nov 17, 2015 |
| OYE | Flow Cytometric Reagents And Accessories. | Class II | Hematology | Contract manufacturing | Aug 3, 2015 |