Positive Control Direct Antigen Kit Suppliers
www.invernessmedical.com | Send Inquiry | Phone: +1-(781)-647-3900
FDA Registration: 3004011380 Year Established: 2005 Annual Revenues: USD 25-50 Million Employee Count: ~180 Quality: CE Certified
Products: Ovulation (Luteinizing Hormone) Test Kits, Fertility Monitors, Pregnancy Test Kits, Home pregnancy test kits, Hcg, Pregnancy Test Kit, Human Chorionic Gonadotropin Test, Fertility Monitoring Test, ...
Inverness Medical Innovations, Inc. manufactures, markets & distributes agents for use in women's health, cardiology and infectious disease. We offer research, development and supply of professional d more...
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.
Classification. Class I (general controls). Except when used in donor screening tests, unassayed material is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.
