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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, Eastern
Minaris Medical America, Inc.
84502
In Commercial Distribution

  • 00813382010105 ()
84502

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
OPTIGEN Negative Control
Minaris Medical America, Inc.
82062
In Commercial Distribution

  • 00813382010099 ()
  • 00813382010310 ()
82062

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
OPTIGEN Positive Control
Minaris Medical America, Inc.
82061
In Commercial Distribution

  • 00813382010082 ()
  • 00813382010327 ()
82061

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
Not in Commercial Distribution

  • 00813382010075 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
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
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