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Address: 370 West 1700 South, Logan, Utah 84321, USA
www.wescor.com |
Send Inquiry |
Phone: +1-(435)-752-6011, 800- 453-2725
FDA Registration: 1717966 Year Established: 1970
Annual Revenues: USD 10-25 Million
Employee Count: ~100
Quality: ISO, CE Certified
Products: Slide Stainers, General Diagnostic Supplies, Programmable Slide Stainers, Hematology Slide Stainer Instruments, Neurology Instruments, General Chemistry Kits, ...
Wescor manufactures & markets instrumentation & other products for medicine, science and industry. Our unique vapor pressure and colloid osmometers, automatic slide stainers, cytocentrifuges & diagnos
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Address: 13665 Dulles Technology Drive, Herndon, Virginia 20171-4603, USA
www.focusdx.com |
Phone: +1-(703)-480-2500
FDA Registration: 2023365
Products: Alcohol (Ethanol) Saliva Test Kits, Allergy skin Test Kit, Allergy Blood Test Kit, Allergy Patch Test Kit, Alanine Aminotransferase Testing Kit, 11-keto Testosterone EIA Kit, ...
Focus Diagnostics, Inc. develops & markets quality services for rare, unusual and emerging infectious & immunologic diseases. We are an ISO 13485 certified company. We offer products like HerpeSelectr
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Address: 918 Deming Way, Suite 201, Madison, Wisconsin 53717, USA
www.eragen.com |
Send Inquiry |
Phone: +1-(608)-6629000
FDA Registration: 3003232610 Quality: ISO 13485 Certified
Products: Analyte Specific Reagents, Asr Reagents (FDA Code:
MVU), Computer Softwares, Diagnostic Reagents, Research Reagents, In Vitro Diagnostic Reagents, Not Assay Specific Internal Polymerase Chain Reaction Control (FDA Code:
OLD), ...
Eragen Biosciences, Inc. deals with clinical laboratories and medical research. Our products are analyte specific reagents, in vitro diagnostic reagents and research use only Reagents. We provide Mult
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EMAIL INQUIRY to 3 Not Assay Specific Internal Polymerase Chain Reaction Control suppliers
FDA Code / Regulation: OLD / 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.