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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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Procellera Single Layer - 00810198030389

Procellera Single Layer OTC, 4"x 4"
Vomaris Wound Care, Inc.
4" x 4"
In Commercial Distribution

  • 00810198030389 ()
VSC-0404

  • Bioelectric wound dressing

Procellera Single Layer - 00810198030372

Procellera Single Layer OTC, 2"x2"
Vomaris Wound Care, Inc.
2"x 2"
In Commercial Distribution

  • 00810198030372 ()
VSC-0202

  • Bioelectric wound dressing

Procellera Single Layer - 00810198030310

Procellera Single Layer Rx 12" x 12"
Vomaris Wound Care, Inc.
12" x 12"
In Commercial Distribution

  • 00810198030358 ()
  • 00810198030310 ()
  • 00810198030365 ()
VSR-1212

  • Portable pneumatic high-frequency ventilator

Procellera Single Layer - 00810198030303

Procellera Single Layer Rx 8" x 8"
Vomaris Wound Care, Inc.
8" X 8"
In Commercial Distribution

  • 00810198030327 ()
  • 00810198030303 ()
  • 00810198030334 ()
  • 00810198030341 ()
VSR-0808

  • Bioelectric wound dressing

Procellera Single Layer - 00810198030013

Procellera Single Layer Rx, 4" x 8"
Vomaris Wound Care, Inc.
4" x 8"
In Commercial Distribution

  • 00810198030013 ()
  • 10810198030010 ()
VSR-0408

  • Bioelectric wound dressing

TIBC Calibrator Set - 00812137012173

For calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay on automated chemistry analyzer systems. Using the Direct TIBC reagents, measurement of the total iron-binding capacity of serum occurs in a fully automated manner, without the need for any off-line separation. Since the entire reaction process is monitored by the chemistry analyzer, it is necessary to calibrate the assay with serum-based calibrators which are carried through the same reaction process as the patient specimens.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
2 x 2mL
In Commercial Distribution

  • 00812137012173 ()
  • 00812137012463 ()
502-157

  • Total iron binding capacity (TIBC) IVD, calibrator

CRP Calibrator Set - 00812137012142

The CRP Calibrator Set is intended to be used for the calibration of the CDS CRP Reagents. For in vitro diagnostic use only. The calibrators in this kit contain known quantities of human C-reactive protein. These reagents are to be used as calibrators with the manufacturer’s CRP Reagents.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
5 x 2mL
In Commercial Distribution

  • 00812137012142 ()
  • 00812137012432 ()
502-154

  • C-reactive protein (CRP) IVD, calibrator

Chemistry Control Level I Set - 00812137012128

The Chemistry Control Level I 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.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
10 x 5mL
In Commercial Distribution

  • 00812137012128 ()
  • 00812137012388 ()
502-152

  • Multiple-type clinical chemistry analyte profile IVD, control

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

HbA1c Calibrator Set - 00812137012203

This product is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
4 x 0.5mL
In Commercial Distribution

  • 00812137012203 ()
  • 00812137012456 ()
502-189

  • Glycated haemoglobin (HbA1c) IVD, calibrator
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