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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k162298 B. Purpose for Submission: New Device C. Measured: 25hydroxyvitamin D. Type of Test: Quantitative
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How to fill out quantitative chemiluminescent immunoassay

01
Collect the sample that needs to be tested.
02
Prepare the sample by following the specific instructions provided by the assay kit manufacturer.
03
Label the assay plate with the necessary information.
04
Dispense the sample and any required reagents into the designated wells of the assay plate.
05
Incubate the plate at the recommended temperature and duration for the assay.
06
After incubation, wash the plate to remove any unbound substances.
07
Add the chemiluminescent reagent to the wells, ensuring that it covers the entire surface.
08
Allow the chemiluminescent reaction to occur for the specified time.
09
Use a luminometer to measure the emitted light from each well.
10
Analyze the obtained data using appropriate software or calculations.
11
Interpret the results according to the assay's calibration standards or reference ranges.

Who needs quantitative chemiluminescent immunoassay?

01
Quantitative chemiluminescent immunoassay is needed by various professionals and organizations in the field of biomedical research, clinical diagnostics, and pharmaceutical development.
02
This assay is commonly used by medical laboratories, healthcare providers, and researchers to measure the concentration of specific analytes (proteins, hormones, drugs, etc.) in biological samples.
03
It is particularly useful in diagnosing and monitoring diseases, assessing drug efficacy, and monitoring patients' response to treatment.
04
Hospitals, clinics, academic research institutions, and pharmaceutical companies are examples of entities that often require quantitative chemiluminescent immunoassay for their work.
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Quantitative chemiluminescent immunoassay is a laboratory technique used to measure the concentration of a specific analyte in a sample using chemiluminescence.
Healthcare professionals and researchers may be required to file quantitative chemiluminescent immunoassay depending on the specific protocols and procedures.
Quantitative chemiluminescent immunoassay is typically carried out by following a standardized protocol provided by the manufacturer of the assay kit.
The purpose of quantitative chemiluminescent immunoassay is to determine the concentration of a specific analyte in a sample for diagnostic or research purposes.
The information reported on quantitative chemiluminescent immunoassay may include the concentration of the analyte, sample details, assay conditions, and any relevant controls.
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1825 2000 vitd clsi calibrator a2 reactivity advia d3 predicate biotinylated exl chemiluminescent linearity rmp calibrators loq monoclonal vdsp reactant d2 k110586 hydroxyvitamin edta 5th sensibeads k162298 hama k2 ep07 chemibeads ghent vitamind equivalen

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