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Negative Control Serological Kit Suppliers

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Shared Systems, Inc. | Address: PO Box 211587, 3961 Columbia Rd, Augusta, Georgia 30917, USA USA
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...
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 EMAIL INQUIRY to  1 Negative Control Serological Kit suppliers  
FDA Code / Regulation: MJY / 862.1660

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.

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