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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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CDS Hematology Calibrator - 00812137010421

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.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
1 x 4.5mL
In Commercial Distribution

  • 00812137010421 ()
502-068

  • Full blood count IVD, calibrator

CDS-LTX PRIMER - 00812137010261

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

Boule Con-Diff Tri-Level - 00812137010230

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 - 00812137010223

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

Boule Con-Diff Tri-Level - 00812137010216

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

YO Home Sperm Test - 07290016650235

No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For iPhone X
In Commercial Distribution

  • 07290016650235 ()
YO-FA-01475-00

  • Motile sperm concentration IVD, kit, imaging, self-testing

Alef Spiral Implant - 07290018434260

No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
6.0 x 13
In Commercial Distribution

  • 07290018434260 ()
AL6013

  • Dental implant system

Alef Spiral Implant - 07290018434253

No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
6.0 x 11.5
In Commercial Distribution

  • 07290018434253 ()
AL6011

  • Dental implant system

Alef Spiral Implant - 07290018434246

No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
6.0 x 10
In Commercial Distribution

  • 07290018434246 ()
AL6010

  • Dental implant system

Alef Spiral Implant - 07290018434239

No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
6.0 x 8
In Commercial Distribution

  • 07290018434239 ()
AL6008

  • Dental implant system
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