CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Address:1800 N.W. 65TH AVE.,PLANTATION,FL,33313,US

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- Catalog Number : 501-417

Device Description : For the in vitro quantitative determination of Triglycerides in serum or plasma. For the in vitro quantitative determination of Triglycerides in serum or plasma. Triglycerides determinations are of interest in the diagnosis and treatment of atherosclerosis, poorly controlled diabetes mellitus, nephrosis, liver disease, or other diseases involving lipid metabolism.

Device Class : 1

Duns Number: 048144997

Premarket Exempt : Yes

Product Code : CDT

Prescription Use : No

Device Count : 1

Device Description : For in vitro diagnostic use as a control to monitor the performance of multi- pa For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Tri-Level is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.

Device Class :

Duns Number: 048144997

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 6

- Catalog Number : 501-606

Device Description : Boule Cal Hematology Calibrator is manufactured for calibration multi-pa Boule Cal Hematology Calibrator is manufactured for calibration multi-parameter hematology analyzers.Multi-parameter hematology analyzers require regular calibration in order to produce accurate results on patient samples. Calibration can be accomplished by transferring information to the analyzer through fresh blood samples, which have been assayed by reference methods. A more direct and convenient approach is to use a calibrator material with System Specific Values (SSV) assigned. Boule Cal is such a material.Boule Cal is a stable suspension of red blood cells, white blood cells and platelets. Assigned values are derived from replicate analyses on whole blood calibrated hematology analyzers (see reference procedures). A user analyzes Boule Cal on their instrument and computes calibration factors by comparing recovered values and assigned values. These factors provide the basis for making adjustments to the instrument.

Device Class : 2

Duns Number: 048144997

Premarket Exempt : No

Product Code : KRZ

Prescription Use : No

Device Count : 1

Device Description : For in vitro diagnostic use as a control to monitor the performance of multi- pa For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.

Device Class :

Duns Number: 048144997

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 9

Device Description : For in vitro diagnostic use as a control to monitor the performance of multi-par For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. CDS 3PD Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific CDS reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product and should be considered a suggested average until you establish your own running mean.

Device Class :

Duns Number: 048144997

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 6

- Catalog Number : 502-006

Device Description : CDS-LTX Control is used to validate volume, conductivity and light scatter param CDS-LTX Control is used to validate volume, conductivity and light scatter parameters on COULTER HmX/ MAXM, STKS and GEN-S instruments. Prepare instrument with CDS LTX Primer immediately prior to CDS-LTX Control measurements.Accurate differential and reticulocyte measurements on COULTER HmX/MAXM, STKS and GEN-S instruments are assured by demonstrating consistent performance of volume, conductivity and light scatter parameters, using a particle of uniform size with appropriate light scattering characteristics. CDS-LTX Control validates the stability of the electrical processing and fluidic flow rate systems used to measure volume, conductivity and light scatter.

Device Class :

Duns Number: 048144997

Premarket Exempt : No

Product Code : KRX

Prescription Use : No

Device Count : 6

- Catalog Number : 502-007

Device Description : CDS-LTX Primer is used to prepare the tubing and instrument components on the CO CDS-LTX Primer is used to prepare the tubing and instrument components on the COULTER HmX/MAXM, STKS and GEN-S instruments prior to analyzing CDS LTX Control.The Coulter HmX/MAXM, STKS and GEN-S instruments require a clean sample line prior to aspirating CDS LTX-Control. Otherwise, performance might be adversely affected through increased coefficients of variation for the volume, conductivity and light scatter parameters.

Device Class :

Duns Number: 048144997

Premarket Exempt : No

Product Code : KRY

Prescription Use : No

Device Count : 6

Device Description : CDS Hematology Calibrator is manufactured for calibration of multi-parameter hem CDS Hematology Calibrator is manufactured for calibration of multi-parameter hematology analyzers for WBC, RBC, Hgb, MCV, Plt and MPV, as applicable to the analyzer system. Multi-parameter hematology analyzers require periodic calibration in order to produce accurate results on patient samples. Calibration may be accomplished by transferring calibration factors to the analyzer through fresh blood samples that have been assayed by reference methods. However, a more direct and convenient approach is to use a calibrator material such as CDS Hematology Calibrator, having system-specific assigned values, derived from a carefully calibrated analyzer or group of analyzers.CDS Hematology Calibrator assigned values are derived from replicate analyses on whole blood calibrated hematology analyzers (see reference procedures). Replicate analyses are performed on the user’s analyzer and calibration factors are computed by comparing recovered values and assigned values. The CDS Hematology Calibrator values are then divided by these determined factors to provide calibration settings for making adjustments to the instrument. Hct, MCH, MCHC, RDW and the WBC differential parameters do not require calibration.

Device Class : 2

Duns Number: 048144997

Premarket Exempt : No

Product Code : KRZ

Prescription Use : No

Device Count : 1

Device Description : For in vitro diagnostic use as a control to monitor the performance of multi-par For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. CDS 3PD Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific CDS reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product and should be considered a suggested average until you establish your own running mean.

Device Class :

Duns Number: 048144997

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 6

Device Description : CDS Hematology Calibrator is manufactured for calibration of multi-parameter hem CDS Hematology Calibrator is manufactured for calibration of multi-parameter hematology analyzers for WBC, RBC, Hgb, MCV, Plt and MPV, as applicable to the analyzer system. Multi-parameter hematology analyzers require periodic calibration in order to produce accurate results on patient samples. Calibration may be accomplished by transferring calibration factors to the analyzer through fresh blood samples that have been assayed by reference methods. However, a more direct and convenient approach is to use a calibrator material such as CDS Hematology Calibrator, having system-specific assigned values, derived from a carefully calibrated analyzer or group of analyzers.CDS Hematology Calibrator assigned values are derived from replicate analyses on whole blood calibrated hematology analyzers (see reference procedures). Replicate analyses are performed on the user’s analyzer and calibration factors are computed by comparing recovered values and assigned values. The CDS Hematology Calibrator values are then divided by these determined factors to provide calibration settings for making adjustments to the instrument. Hct, MCH, MCHC, RDW and the WBC differential parameters do not require calibration.

Device Class : 2

Duns Number: 048144997

Premarket Exempt : No

Product Code : KRZ

Prescription Use : No

Device Count : 1