Positive Control Serological Kit Suppliers
www.orthoclinical.com | Send Inquiry | Phone: +1-(800)-828-6316
FDA Registration: 1319809 Year Established: 1937
Products: Immunoassay Systems, Troponin I, Myoglobin (FDA Code: DDR), Hepatitis B Surface Antibody Test Kits, Hepatitis B Surface Antigen Test Kits, Hepatitis C Antibody Test Kits, ...
Ortho-clinical Diagnostics, Inc. provides diagnostic products and services for the global health care community. We deliver accurate, timely & cost-effective solutions for screening, diagnosing, monit more...
Send Inquiry | Phone: +1-(706)-868-0408, 888-474-2733
Year Established: 1991 Annual Revenues: < USD 1 Million Quality: ISO 9001 Certified
Products: Infectious Disease Testing Viral Quality Control kits, Electrodes and Other Components, Gold Cup Electrodes, Culture Media Quality Control Kit (FDA Code: JTR), Cholesterol Colorimetric Test (FDA Code: CGO), HDL Precipitation Method (FDA Code: LBR), Bacterial Diagnostic Test, ...
Shared Systems, Inc. is a provider of non-serum based blocking buffers. Our in vitro diagnostic kits include microbiology, serology, HDL cholesterol and infectious disease. more...
www.bbii.com | Phone: +1-(508)-580-1900
FDA Registration: 2022994 Annual Revenues: USD 5-10 Million Quality: ISO 9001, CE Certified
Products: Controls, Controls for Diagnostic Equipment, Blood Bank Test Kits, Immunoassays, Infectious Disease Test Kits, Multi Analyte Control (FDA Code: JJY), ...
BBI Diagnostics manufactures biological based materials. Our products are used in diagnostic tests, commercial bioproduction of therapeutic drugs and additional research applications. We focus on biot more...
www.seracare.com | Send Inquiry | Phone: +1-(508)-244-6400
FDA Registration: 3007088335 Year Established: 1984 Annual Revenues: USD 25-50 Million Employee Count: ~50 Quality: ISO Certified
Products: Preps & Swabs, Cotton Swabs, Laboratory Centrifuges, Floor, Laboratory Information Systems (LIS), Software, Clinical Laboratory Information Systems (LIS), Benchtop Centrifuges, ...
SeraCare Life Sciences, Inc. manufactures and sells biological based materials. We focus on biotechnology, pharmaceutical and diagnostic industries. We are certified with ISO 13485 standard. Our produ 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.
