Maine Standards Company, LLC

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Web: http://www.mainestandards.com
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Address: 765 Roosevelt Trail, Suite 9A, Windham, Maine 04062-5365, USA
Phone: +1-(207)-892-1300, 800-377-9684 | Fax: +1-(207)-892-2266 | Map/Directions >>

Profile: Maine Standards Company, LLC specializes in calibration verification and linearity. Our Validate® test kits are linearity test sets designed for calibration verification, reportable range validation and new instrument linearity testing. We offer Validate® chem for easier calibration verification / linearity testing of general chemistries. Our chem products include 30 general chemistries, enzymes and select lipids. We also provide Validate® Osmo for easier calibration verification/linearity testing of serum and urine osmolality.

The company was founded in 2001, has revenues of USD 1-5 Million, has ~20 employees and is ISO certified.

FDA Registration Number: 1226774

5 Products/Services (Click for related suppliers)

• Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 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.

• 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.)

• Enzymes

• Multi Analyte Control (FDA Code: JJY / 862.1660)

• 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.)