Biocell Laboratories, Inc.

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Contact: Marc McKonic - President
Web: http://www.biocell.com
E-Mail:
Address: 2001 E. University Dr., Rancho Dominguez, California 90220-6411, USA
Phone: +1-(310)-537-3300, 800-222-8382 | Fax: +1-(310)-637-3927 | Map/Directions >>

Profile: Biocell Laboratories, Inc. provides plasma fractions, sera and custom products. We produce bovine serum albumin and bovine gamma globulin utilizing the Cohn cold ethanol precipitation process. We also produce human, goat, mouse, rabbit, and sheep albumin and gamma globulin. This process is optimal for preserving the nutrient factors critical to the applications of cell culture, leptospira and microbiological growth. We utilize the heat-shock process which diminishes the nutrients and contains residual caprylic acid. Our built-in alert system prevents deviations from the manufacturing process. Our capabilities include lyophilization, aseptic and sterile liquid precision filling, temperature controlled processing & storage, custom labeling & on-site laboratory analysis. We specialize in the manufacture of liquid and lyophilized calibrators.

The company has revenues of USD 5-10 Million, has ~40 employees and is ISO 9001 certified.

FDA Registration Number: 2077563

33 Products/Services (Click for related suppliers)

• Absorbable Collagen Hemostatic Sponge

• Albumin Antigen Antiserum Control (FDA Code: DCF / 866.5040)

An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

• Alpha-1-Acid-Glycoprotein Antigen (FDA Code: LKL / 866.5420)

Analpha- 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha- 1-glycoproteins (a group of plasma proteins found in thealpha- 1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specificalpha- 1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

• Alpha-2-Macroglobulin (FDA Code: DEB / 866.5620)

Analpha -2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -2-macroglobulin (a serum protein) in plasma. Measurement ofalpha -2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.

• 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.

• Calibration Reagent

• Cerebrospinal Fluid Reservoir

• Complement C3 (FDA Code: CZW / 866.5240)

A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

• Complement C4 (FDA Code: DBI / 866.5240)

• Culture Media Supplements (FDA Code: JSK / 866.2450)

A supplement for culture media is a device, such as a vitamin or sugar mixture, that is added to a solid or liquid basal culture medium to produce a desired formulation and that is intended for medical purposes to enhance the growth of fastidious microorganisms (those having complex nutritional requirements). This device aids in the diagnosis of diseases caused by pathogenic microorganisms.

• Electrolyte Control (FDA Code: JJR / 862.1660)

• Enriched Culture Media (FDA Code: KZI / 866.2330)

An enriched culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify fastidious microorganisms (those having complex nutritional requirements). The device consists of a relatively simple basal medium enriched by the addition of such nutritional components as blood, blood serum, vitamins, and extracts of plant or animal tissues. The device is used in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

• Enzyme Controls (FDA Code: JJT / 862.1660)

• Fertility Products, Human Serum Albumin

• Fraction V Albumin

• General Biological Serum

• General Nutrient Broth Culture Media (FDA Code: JSC / 866.2350)

A microbiological assay culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate selected test microorganisms in order to measure by microbiological procedures the concentration in a patient's serum of certain substances, such as amino acids, antimicrobial agents, and vitamins. The concentration of these substances is measured by their ability to promote or inhibit the growth of the test organism in the innoculated medium. Test results aid in the diagnosis of disease resulting from either deficient or excessive amounts of these substances in a patient's serum. Tests results may also be used to monitor the effects of the administration of certain antimicrobial drugs.

• Haptoglobin (FDA Code: DAD / 866.5460)

A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.

• Human and Animal Sera (FDA Code: KIS / 864.2800)

Animal and human sera are biological products, obtained from the blood of humans or other animals, that provide the necessary growth-promoting nutrients in a cell culture system.

• Human Serum

• IGA Control (FDA Code: CZP / 866.5510)

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

• IgG Control (FDA Code: DEW / 866.5510)

• Immunoglobulin M (IgM) (FDA Code: DFT / 866.5550)

An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

• Lipid Standard

• 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.)

• RIA Digitoxin Control Serum (FDA Code: DJK / 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.

• Secondary Antibody Test (FDA Code: KTS / 866.5510)

• Spinal Fluid Reservoir

• Transferrin Antigen (FDA Code: DDG / 866.5880)

A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

• Urinalysis Controls (FDA Code: JJW / 862.1660)

• Whole Blood Plasma (FDA Code: DGQ / 866.5700)

A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by immunochemical techniques the proteins in plasma or serum. Measurements of proteins in plasma or serum aid in the diagnosis of any disease concerned with abnormal levels of plasma or serum proteins, e.g., agammaglobulinemia, allergies, multiple myeloma, rheumatoid vasculitis, or hereditary angioneurotic edema.

• Whole Human Serum (FDA Code: DGR / 866.5700)