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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: Myoglobin (FDA Code:
DDR), Ovulation (Luteinizing Hormone) Test Kits, Fertility Monitors, Pregnancy Test Kits, Home pregnancy test kits, Hcg, Influenza A and B Testing rapid Influenza Testing, Automated Urinalysis System (FDA Code:
KQO), ...
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.