Scytek Laboratories, Inc.

Click Here To EMAIL INQUIRY
Web: http://www.scytek.com
E-Mail:
Address: 205 South 600 West, Logan, Utah 84321, USA
Phone: +1-(435)-755-9848, 800-729-8350 | Map/Directions >>

Profile: Scytek Laboratories, Inc. provides contract/custom manufacturing of a variety of reagents for enzyme immunoassay, immunohistochemistry, histology and cytology. Our Alk-Phos Blue creates a stark contrast, intense blue color, when in need of a double-staining alternative. It is available in a 60ml pack of working solution. The kit includes 60ml of buffer, 2ml of concentrate, 2ml of activator, a mixing vial, and transfer pipette. We solve complex problems in R&D, formulation, manufacturing, vialing, kit assembly, scheduling, inventory, and distribution.

FDA Registration Number: 3004074729

17 Products/Services (Click for related suppliers)

• Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020)

Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to:

• Eosin Y Stain (FDA Code: HYB / 864.1850)

Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

• Formalin Containing Fixative (FDA Code: LDY / 864.4010)

• General Purpose Reagent (FDA Code: LDT)

• Hematoxylin Stain (FDA Code: HYJ / 864.1850)

• Hematoxylin Stain Solution with Phosphotungstic Acid

• Immunohistochemistry Reagents And Kits (FDA Code: NJT / 864.1860)

Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.

• Mayer's Hematoxylin Stain (FDA Code: HYL / 864.1850)

• Methyl Green Stain (FDA Code: HZA / 864.1850)

• Molecular Analyte Specific Reagents (ASR)

• Neutral Buffered Formalin (FDA Code: IFP / 864.4010)

• Nuclear Fast Red Stain (FDA Code: HZF / 864.1850)

• pH Buffer (FDA Code: JCC / 864.4010)

• pH Buffer Calibration Solutions

• Synthetic Cell and Tissue Culture Media and Components (FDA Code: KIT / 864.2220)

Synthetic cell and tissue culture media and components are substances that are composed entirely of defined components (e.g., amino acids, vitamins, inorganic salts) that are essential for the survival and development of cell lines of humans and other animals. This does not include tissue culture media for human ex vivo tissue and cell culture processing applications as described in 876.5885 of this chapter.

• Trypsin (FDA Code: IBG / 864.4400)

Enzyme preparations are products that are used in the histopathology laboratory for the following purposes:

• Water Soluble Mounting Media (FDA Code: KEQ / 864.4010)