Irvine Scientific

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Contact: Ms. Pat Ferns - VP Sales
Web: http://www.irvinesci.com
E-Mail:
Address: 2511 Daimler St., Santa Ana, California 92705-5588, USA
Phone: +1-(949)-261-7800, 800-437-5706 | Fax: +1-(949)-261-6522 | Map/Directions >>

Profile: Irvine Scientific specializes in cell culture media. We provide advanced media and related products to manufacturers of diagnostic and pharmaceutical products, as well as the cytogenetic, reproductive & clinical laboratories. We sell products in a variety of markets, including media and other related cell culture systems, specialty bulk sera products, media for the cytogenetics laboratory as well as a complete product line for the reproductive laboratory. Our cell culture products are used in industrial bioprocessing, in-vitro diagnostics and other cell culture applications. Our reproductive products are used in ART procedures including vitrification, fertilization, cryopreservation and embryo culture and transfer. Our prenatal products are optimized for the culture of human amniotic fluid cells, bone marrow and blood cell culture.

The company was founded in 1970, has revenues of USD 10-25 Million, has ~40 employees and is ISO 9001, CE certified.

FDA Registration Number: 2022379

15 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:

• Artificial Insemination Cannulas

• Assisted Reproduction Catheter (FDA Code: MQF / 884.6110)

Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.

• Chromosome Culture Kit (FDA Code: KIQ / 864.2260)

A chromosome culture kit is a device containing the necessary ingredients (e.g., Minimum Essential Media (MEM) of McCoy's 5A culture media, phytohemagglutinin, fetal calf serum, antibiotics, and heparin) used to culture tissues for diagnosis of congenital chromosome abnormalities.

• Fertility Products, Embryo Transfer Catheter

• Fertility Products, Oocyte Retrieval Needle

• Globulin Turbidimetric Method (FDA Code: JGE / 862.1330)

A globulin test system is a device intended to measure globulins (proteins) in plasma and serum. Measurements of globulin are used in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.

• Intrauterine Insemination Cannula (FDA Code: MFD / 884.5250)

A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.

• Mycoplasma Detection Kit (FDA Code: KIW / 864.2360)

Mycoplasma detection media and components are used to detect and isolate mycoplasma pleuropneumonia-like organisms (PPLO), a common microbial contaminant in cell cultures.

• Reagent Contract Manufacturing

• Selective and Differential Culture Media (FDA Code: JSI / 866.2360)

A selective culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify certain pathogenic microorganisms. The device contains one or more components that suppress the growth of certain microorganisms while either promoting or not affecting the growth of other microorganisms. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

• Semen Analysis Device (FDA Code: MNA)

• Sperm Collection Electrical Stimulator (FDA Code: LNL)

• 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.

• Tissue Culture Apparatus