Synergent Biochem, Inc.

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Web: http://www.synergentbiochem.com
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Address: 12026 Centralia Ave., Unit G & H, Hawaiian Gardens, California 90716, USA
Phone: +1-(562)-809-3389 | Fax: +1-(562)-809-6191 | Map/Directions >>

Profile: Synergent Biochem, Inc. designs and manufactures clinical chemistry, toxicology controls and calibrators for in vitro diagnostic marketplace. We offer drug of abuse and liquid lipid products. The drug of abuse products are urine DOA screening, urine DOA on-site and saliva DOA control. A bi-level liquid urine DOA screening quality control material is intended for use in monitoring the accuracy and precision of immunoassay screening methods. Our liquid lipid controls are used to monitor the accuracy and precision of serum lipid determinations. The liquid HDL or LDL calibrator is intended for calibrating homogeneous assays for HDL and LDL cholesterol. These are stable, human serum base ready to use liquid, and has 30-day open vital stability, & 18 month refrigerated shelf-life.

The company was founded in 2000.

FDA Registration Number: 2032335

8 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 Control Materials (FDA Code: DIF / 862.3280)

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

• HDL/LDL Calibrator

• Liquid Lipid Controls

• 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.)

• Saliva DOA Screening Controls

• Urine DOA Screening Controls