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Biochemical Diagnostics, Inc.

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Contact: Amir Faroogi - VP Manufacturing
Web: http://www.biochemicaldiagnostics.com
E-Mail:
Address: 180 Heartland Blvd., Edgewood, New York 11717-8314, USA
Phone: +1-(631)-595-9200, 800-223-4835 | Fax: +1-(631)-595-9204 | Map/Directions >>
 
 

Profile: Biochemical Diagnostics, Inc. specializes in offering column hardware, liquid urine controls, thin layer chromatography, and microtiter configured sample preparation hardware. The Detectabuse controls are designed to monitor and validate the performance of drugs of abuse detection methods at levels established by SAMHSA, CAP/AACC & many state programs. The Detectabuse control urines are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents. This product is intended to be used by health care professionals as an integral part of good laboratory practices. Pregnancy-Skreen™ controls are prepared from human based urine available as a negative and at positive hCG levels to qualitatively monitor the performance of urine pregnancy immunochromatographic detection devices & procedures. The Pregnancy-Skreen™ product line of controls is manufactured using a human based urine matrix that has been stabilized to insure that the product will be viable until the date of expiration. The positive control is spiked with hCG in a target range from 200-400 mIU/mL of urine matrix. The negative control is prepared from a urine pool that tested negative for hCG. We offer Multi-Prep® Gravity series GVSA column methods for the analysis of methylmalonic acid and homocysteine in serum using GC-MS. These methods involve sample preparation on the Multi-Prep GVSA column, a strong anion exchange gravity flow column, and measurement by GC-MS using MMA-D3 and Homocystine-D8 as internal standards. Homocysteine is protected from oxidation with the use of a proprietary stabilizer.

The company was founded in 1981, has revenues of USD 1-5 Million, has ~20 employees and is CE certified.

FDA Registration Number: 2432495

9 Products/Services (Click for related suppliers)  
• 17-Hydroxycorticosteroids Porter Silber Hydrazone (FDA Code: CDB / 862.1385)
A 17-hydroxycorticosteroids (17-ketogenic steroids) test system is a device intended to measure corticosteroids that possess a dihydroxyacetone
• 17-Ketogenic Steroids Zimmerman/Norymberski (FDA Code: CCZ / 862.1385)
• 17-Ketosteroids Zimmerman (Spectrophotometric) (FDA Code: CCY / 862.1430)
A 17-ketosteroids test system is a device intended to measure 17-ketosteroids in urine. Measurements of 17-ketosteroids are used in the diagnosis and treatment of disorders of the adrenal cortex and gonads and of other endocrine disorders, including hypertension, diabetes, and hypothyroidism.
• 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.
• P-Nitroaniline/Vanillin Vanilmandelic Acid Diazo Test (FDA Code: CDF / 862.1795)
A vanilmandelic acid test system is a device intended to measure vanilmandelic acid in urine. Measurements of vanilmandelic acid obtained by this device are used in the diagnosis and treatment of neuroblastoma, pheochromocytoma, and certain hypertensive conditions.
• Reagents
• Thin Layer Chromatography
• Urine Screening Kit (FDA Code: JXA / 866.2660)
A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

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