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Address: 51 Sawyer Rd., Suite 200, Waltham, Massachusetts 02453-3448, USA
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
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Address: 338 North Canal St., #9, South San Francisco, California 94080, USA
Phone: +1-(650)-872-7788
Products: pH Buffer (FDA Code:
JCC), pH Buffer Calibration Solutions, IGG Immunoassay Reagents (FDA Code:
KTO), ...
Ease Labs, Inc. manufactures IGG immunoassay reagents, pH buffer and pH buffer calibration solutions.
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Address: Industrie Park Noord 32, Beernem 8730, Belgium
www.fertipro.com |
Send Inquiry |
Phone: +32-(50)-791805
FDA Registration: 3003272500 Quality: ISO 9001, ISO13485, CE Mark Certified
Products: IGG Immunoassay Reagents (FDA Code:
KTO), Reproductive Media (FDA Code:
MQL), Chemical Solution Stain (FDA Code:
LED), ...
Ferti Pro N.V. specializes in the manufacture of diagnostics and cell culture media for assisted reproductive techniques & diagnosis of male infertility. Our products include Spermmar IgA, Spermmar Ig
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FDA Code / Regulation: KTO / 866.5530 An immunoglobulin G (Fc fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fc (carbohydrate containing) fragment of immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming abnormalities, e.g., gamma heavy chain disease.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.