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Address: Landsteiner Str. 5, Dreieich 63303, Germany
www.biotest.de |
Send Inquiry |
Phone: +49-(6903)-801 -0
FDA Registration: 9610824
Products: Ophthalmology, Surgical Instrument Trays, Surgical Instrument Tray (FDA Code:
FSM), Hla-dqb Typing Kit (FDA Code:
MVS), Leukocyte Typing Test (FDA Code:
LGO), Non-diagnostic for HLA Quantitative Test (FDA Code:
MZH), Whole Human Serum (FDA Code:
DGR), ...
Biotest AG specializes in immunology and hematology. Our product area includes pharmaceuticals and diagnostics. Our pharmaceuticals include plasma proteins and bio therapeutics. Our immunoglobins incl
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Address: 123 Mill Arbour Lane, Thornhill, Ontario L4J 6M8, Canada
Phone: +1-(416)-568-7919
Products: Whole Blood Plasma (FDA Code:
DGQ), Whole Human Serum (FDA Code:
DGR), Human/Horse/Rabbit Coagulase Plasma (FDA Code:
JTL), Mycoplasma Spp Antiserum (FDA Code:
GSA), ...
Complex Pharma, Inc. provides mycoplasma spp antiserums, whole human serums and whole blood plasmas.
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Address: 71-73 Railway Parade, Marrickville, NSW 2204, Australia
www.bioclone.com.au |
Send Inquiry |
Phone: (0)2 9517-1966, 800-251-
Year Established: 1981
Employee Count: ~20
Quality: ISO 9001, CE Certified
Products: Allergy Testing, Elisa Allergy test Kit, Latex Allergy Test Kit, Home Allergy Test Kit, Product Development, Allergy Test Strips, Allergy Test, ...
Bioclone Australia Pty Limited specializes in the design and manufacture of high quality immunodiagnostic products for medical and research laboratory markets. Our focused activities include monoclona
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FDA Code / Regulation: DGR / 866.5700 A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by immunochemical techniques the proteins in plasma or serum. Measurements of proteins in plasma or serum aid in the diagnosis of any disease concerned with abnormal levels of plasma or serum proteins, e.g., agammaglobulinemia, allergies, multiple myeloma, rheumatoid vasculitis, or hereditary angioneurotic edema.
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.