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Sign in to claim this brandCLINICAL DIAGNOSTIC SOLUTIONS, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 1800 N.W. 65TH AVE., PLANTATION, FL, 33313
- Website
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- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3002684533
- DUNS Number
- —
Catalogue (49)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CDS Hematology Calibrator | 1 x 4.5mL | FDA UDI | Class II | Active |
| Direct TIBC Reagent Set | R1 x 90mL, R2 x 60mL | FDA UDI | Class I | Active |
| Uric Acid Reagent | 500mL | FDA UDI | Class I | Active |
| Creatinine Reagent Set | R1 x 500mL, R2 x 125mL | FDA UDI | Class II | Active |
| Albumin Reagent | 500 mL | FDA UDI | Class II | Unknown |
| ALT (SGPT) Reagent Set | R1 x 500mL, R2 x 125mL | FDA UDI | Class I | Active |
| AST (SGOT) Reagent Set | R1 x 500mL, R2 x 125mL | FDA UDI | Class II | Active |
| TIBC Calibrator Set | 2 x 2mL | FDA UDI | Class II | Active |
| CDS 3PD Hematology Control | Tri-Pack 6x4.5 mL | FDA UDI | Class II | Active |
| Carbon Dioxide Reagent | 120mL | FDA UDI | Class II | Active |
| Boule Con-Diff Tri-Level | 12 x 4.5mL | FDA UDI | Class II | Active |
| Total Protein Reagent | 500mL | FDA UDI | Class II | Active |
| Boule Con-Diff Tri-Level | 6 x 4.5mL | FDA UDI | Class II | Active |
| Cds-Ltx Control | 6 x 16 mL | FDA UDI | Class II | Active |
| CRP Control Set | L1 x 3 x 3mL, L2 x 3 x 3mL | FDA UDI | Class II | Active |
| Glucose Reagent | 500mL | FDA UDI | Class II | Active |
| HbA1c Reagent Set | R1 x 30mL, R2 x 10mL, R3 x 125mL | FDA UDI | Class II | Active |
| AMYLASE (CNPG3) Reagent Set | 4 x 120 mL | FDA UDI | Class II | Active |
| HbA1c Control Set | L1 x 2 x 0.5mL, L2 x 2 x 0.5mL | FDA UDI | Class II | Active |
| CRP Reagent Set | R1 x 50mL, R2 x 50mL | FDA UDI | Class II | Active |
| Cds-Ltx Primer | 6 x 16mL | FDA UDI | Class II | Active |
| Alkaline Phosphatase Reagent Set | R1 x 500 mL, R2 x 125 mL | FDA UDI | Class II | Active |
| Magnesium Reagent Set | R1 x 2 x 120mL, R2 x 2 x 120mL | FDA UDI | Class I | Active |
| CDS Hematology Calibrator | 1x3.0mL | FDA UDI | Class II | Active |
| Total Bilirubin Reagent Set | R1 x 500mL, R2 x 15mL | FDA UDI | Class II | Active |
| Boule Cal | 1 x 3.0mL | FDA UDI | Class II | Active |
| Multi-Analyte Lipid Control Set | L1 x 3mL, L2 x 3mL, L3 x 3mL | FDA UDI | Class I | Active |
| Phosphorus Reagent | 500mL | FDA UDI | Class I | Active |
| Chemistry Control Level I Set | 10 x 5mL | FDA UDI | Class I | Active |
| LDL Cholesterol Reagent Set | R1 x 2 x 70mL, R2 x 1 x 50mL | FDA UDI | Class I | Active |
| Calcium Arsenazo III Reagent | 500mL | FDA UDI | Class II | Active |
| Boule Con-Diff Tri-Level | 9 x 4.5mL | FDA UDI | Class II | Active |
| CK-NAC Reagent Set | R1 x 120mL, R2 x 30mL | FDA UDI | Class II | Active |
| Cholesterol Reagent | 500mL | FDA UDI | Class I | Active |
| HbA1c Calibrator Set | 4 x 0.5mL | FDA UDI | Class II | Active |
| LDH Reagent Set | R1 x 500mL, R2 x 125mL | FDA UDI | Class II | Active |
| Triglycerides Reagent | 500mL | FDA UDI | Class I | Unknown |
| Chemistry Calibrator Set | 10 x 5mL, 1 x 50mL | FDA UDI | Class II | Active |
| Urea Nitrogen Reagent Set | R1 x 500mL, R2 x 125mL | FDA UDI | Class II | Active |
| Iron Reagent Set | R1 x 500mL, R2 x 15mL | FDA UDI | Class I | Active |
| GGT Reagent Set | R1 x 500mL, R2 x 125mL | FDA UDI | Class I | Active |
| HDL Cholesterol Reagent Set | R1 x 2 x 70mL, R2 x 1 x 50mL | FDA UDI | Class I | Active |
| Direct Bilirubin Reagent Set | R1 x 500mL, R2 x 15mL | FDA UDI | Class II | Active |
| CRP Calibrator Set | 5 x 2mL | FDA UDI | Class II | Active |
| Chemistry Control Level II Set | 10 x 5mL | FDA UDI | Class I | Active |
| CDS™ 3-PD Hematology Control | Tri-Pack 6x3.0mL | FDA UDI | Class II | Active |
| Cds Ltx Control Latex Particle Suspension And Primer | K993375 | FDA 510(k) | Class II | Active |
| Cds 3-Pd Hematology Controls | K024173 | FDA 510(k) | Class II | Active |
| Cds Hematology Calibrator (cds Cal) | K041130 | FDA 510(k) | Class II | Active |
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FDA Recalls (7)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 2, 2020 | Z-1001-2020 | — | terminated | A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle. |
| Feb 24, 2013 | Z-1436-2014 | — | terminated | Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots. |
| Mar 24, 2011 | Z-0190-2013 | — | terminated | Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complai |
| Mar 24, 2011 | Z-0191-2013 | — | terminated | Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complai |
| Mar 24, 2011 | Z-0189-2013 | — | terminated | Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complai |
| Aug 4, 2010 | Z-0194-2013 | — | terminated | Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule |
| Aug 4, 2010 | Z-0193-2013 | — | terminated | Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule |