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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY. 510(k) Number: k041863 B. Purpose for Submission: New device C. Analyte: Rheumatoid Factor D. Type of Test: Quantitative, Immunoradiometric E.
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Step 1: Gather all the necessary materials such as the quantitative immunoradiometric assay kit, sample tubes, pipettes, and reagents.
02
Step 2: Prepare the samples by labeling the sample tubes and adding the appropriate amount of sample to each tube.
03
Step 3: Add the necessary reagents according to the instructions provided with the kit.
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Step 4: Mix the contents of the sample tubes thoroughly and incubate for the specified time at the recommended temperature.
05
Step 5: After the incubation period, perform the measurements using the designated equipment or instrument.
06
Step 6: Record the results obtained from the measurements and analyze the data accordingly.
07
Step 7: Interpret the results based on the reference values or standards provided in the assay kit manual.
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Step 8: Document the findings and report the quantitative immunoradiometric results as required.
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Step 9: Dispose of any used materials properly and clean the workspace to maintain laboratory hygiene.

Who needs quantitative immunoradiometric?

01
Medical researchers and scientists who are studying specific biomarkers or protein levels in biological samples.
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Diagnostic laboratories and healthcare professionals who require quantitative measurements of certain substances in patient samples.
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Pharmaceutical companies and drug development researchers who need to analyze the efficacy and concentration of specific compounds in experimental samples.
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Biotechnology companies and researchers involved in the development of new assays and diagnostic tests.
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Clinical research institutions and academic laboratories conducting studies related to immunology or related fields.
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Quantitative immunoradiometric is a method used to measure the concentration of specific substances in a sample using antibodies and radioisotopes.
Researchers, scientists, and medical professionals who conduct research or diagnostic tests using immunoradiometric assays may be required to file quantitative immunoradiometric results.
Quantitative immunoradiometric results are typically filled out by recording the measured values of the specific substance being analyzed along with any necessary information about the sample and testing conditions.
The purpose of quantitative immunoradiometric is to accurately measure and quantify the concentration of a specific substance in a sample for research, diagnostic, or monitoring purposes.
Information such as the measured values of the substance, sample details, testing conditions, and any relevant controls or standards used must be reported on quantitative immunoradiometric.
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