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The Chemistry Control Level II is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. For in vitro diagnostic use only. The quality control material is prepared from human serum with enzymes, nonprotein constituents, non-human protein, and bacteriostatic agents added. The constituents were adjusted to the levels listed in Expected Values.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
10 x 5mL
In Commercial Distribution
- 00812137012135 ()
- 00812137012395 ()
502-153
- Multiple-type clinical chemistry analyte profile IVD, control
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.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
12 x 4.5mL
In Commercial Distribution
- 00812137011299 ()
- 00812137011817 ()
501-608
- Full blood count IVD, control
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.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
6 x 16mL
In Commercial Distribution
- 00812137010261 ()
- 00812137011831 ()
502-007
- Reticulocyte count IVD, control
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.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
9 x 4.5mL
In Commercial Distribution
- 00812137010230 ()
- 00812137011800 ()
501-607
- Full blood count IVD, control
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.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
1 x 3.0mL
In Commercial Distribution
- 00812137010223 ()
501-606
- Full blood count IVD, calibrator
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.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
6 x 4.5mL
In Commercial Distribution
- 00812137010216 ()
- 00812137011794 ()
501-605
- Full blood count IVD, control
No Description
BEIJING UNT TECHNOLOGY CO.,LTD
Nd:Yag Pro X
In Commercial Distribution
- 06973663790042 ()
- General/multiple surgical solid-state/carbon dioxide laser system
The Ingenia Elition X with the gradient and RF designs, as well as Compressed SENSE delivers on superb image quality, improves patient handling setup time and combines this with accelerations in both 2D- and 3D scanning.
Philips Medical Systems Nederland B.V.
Ingenia Elition X
In Commercial Distribution
- 00884838104129 ()
782119
- Full-body MRI system, superconducting magnet
Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin.
Philips Medical Systems Nederland B.V.
Ingenia Ambition X
In Commercial Distribution
- 00884838098350 ()
782109
- Full-body MRI system, superconducting magnet
Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system.
Philips Medical Systems Nederland B.V.
5.x IVDR
In Commercial Distribution
- 00884838121263 ()
760042
- Microscope slide digital imaging scanner IVD