Profile: Verichem Laboratories, Inc. develops accurate, protein-based, liquid clinical chemistry reference materials for in vitro diagnostic use. Our entire product line was designed to deliver accurate, liquid reference standards for convenient calibration or calibration verification. We use modern filtration and production filling techniques for each lot, including peristaltic pumping to reduce the risk of cross contamination. Fill volumes are checked throughout the filling process for accuracy and precision in strict accordance with FDA/cGMP regulations. Our Matrix Plus™ cholesterol reference kit is a protein based ready-to-use liquid. It has no glycols, azides or surfactants. Our microprotein standard kit is suitable for any turbidimetric or colorimetric method. It is intended for calibration or calibration verification. It is azide free.
FDA Registration Number: 1221645
7 Products/Services (Click for related suppliers)
|
• Drug Mixture Calibrator (FDA Code: DKB / 862.3200) A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also 862.2 in this part.) |
• Enzyme Controls (FDA Code: JJT / 862.1660) A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls. |
• Ethyl Alcohol Calibrator Test (FDA Code: DNN / 862.3200) |
• General Diagnostic Supplies |
• Multi Analyte Mixture - Calibrator (FDA Code: JIX / 862.1150) A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.) |
• Primary Calibrator (FDA Code: JIS / 862.1150) |
• Secondary Calibrator (FDA Code: JIT / 862.1150) |