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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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KIT, OPTIGEN® Environmental 36 (20T)
Minaris Medical America, Inc.
85068
In Commercial Distribution

  • 00813382010037 ()
85068

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN US Food 30 (100ND)
Minaris Medical America, Inc.
85267
In Commercial Distribution

  • 00813382010020 ()
85267

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN® Food 29 (20T)
Minaris Medical America, Inc.
85067
In Commercial Distribution

  • 00813382010013 ()
85067

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
In Commercial Distribution

  • 00813382010006 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
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 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
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.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Tri-Pack 6x4.5 mL
In Commercial Distribution

  • 00812137010414 ()
  • 00812137011789 ()
502-066

  • Full blood count IVD, control
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.
1x3.0mL
In Commercial Distribution

  • 00812137010360 ()
502-040

  • Full blood count IVD, calibrator
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.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
6 x 16 mL
In Commercial Distribution

  • 00812137010254 ()
  • 00812137011824 ()
502-006

  • Reticulocyte count IVD, control
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.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Tri-Pack 6x3.0mL
In Commercial Distribution

  • 00812137010247 ()
  • 00812137011770 ()
502-004

  • Full blood count IVD, control
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