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This document serves as a premarket notification under Section 510(k) for the Liquichek Tumor Markers Control, intended to be used as an assayed quality control material for laboratory testing procedures.
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How to fill out liquichek tumor markers control

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How to fill out Liquichek Tumor Markers Control

01
Ensure you have all necessary materials ready, including the Liquichek Tumor Markers Control kit.
02
Read the instructions provided in the kit thoroughly before starting.
03
Prepare your workstation by cleaning the surface and gathering pipettes and any other required lab equipment.
04
Follow the specified temperature requirements to allow the control to adjust to room temperature if needed.
05
Use a pipette to transfer the appropriate volume of the Tumor Markers Control into the designated sample containers.
06
Label the samples clearly to avoid any confusion during analysis.
07
Perform any necessary dilutions or preparations as specified in the instructions.
08
Run the control samples through the assay following the usual procedure of your lab's testing method.
09
Document all measurements carefully, following your lab's protocols for record-keeping.
10
Analyze the results according to the guidelines in the kit and your lab's standard operating procedures.

Who needs Liquichek Tumor Markers Control?

01
Clinical laboratories conducting tests for tumor markers.
02
Healthcare professionals requiring quality control for tumor marker assays.
03
Laboratories involved in oncology research.
04
Diagnostic centers that perform cancer screenings.
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People Also Ask about

CA-125 levels in the body are measured by units per millimeter (U/mL). A CA-125 normal range falls between 0 and 35 U/mL. Levels over 35 U/mL may indicate the presence of cancer or other conditions. Not all patients with a high CA-125 result have cancer.
Normal levels of AFP don't rule out cancer because some people with these cancers have normal AFP levels. It means that you're less likely to have a cancer that causes high AFP levels. An extremely high level of AFP in your blood—greater than 400 ng/mL—could be a sign of liver tumors.
High tumor marker results could suggest the presence of cancer. It may also suggest that cancer has progressed or spread (metastasized). But this test alone isn't enough to diagnose cancer. If you have high test results, your healthcare provider will explain what the numbers mean. They may also run additional tests.
Normal range: < 2.5 ng/ml. Normal range may vary somewhat depending on the brand of assay used. Levels > 10 ng/ml suggest extensive disease and levels > 20 ng/ml suggest metastatic disease.
If you have a high level of tumor markers, it only means that you're more likely to have cancer. A biopsy is usually needed to diagnose or rule out cancer. Tumor marker tests that use cells from a tumor may help diagnose cancer. These "tumor cell markers" are usually removed during a biopsy.
High tumor marker results could suggest the presence of cancer. It may also suggest that cancer has progressed or spread (metastasized). But this test alone isn't enough to diagnose cancer. If you have high test results, your healthcare provider will explain what the numbers mean.

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Liquichek Tumor Markers Control is a quality control product used in laboratories to ensure accurate measurement of tumor markers in patient samples.
Laboratories that perform tumor marker testing are required to utilize Liquichek Tumor Markers Control as part of their quality assurance processes.
To fill out Liquichek Tumor Markers Control, follow the manufacturer's instructions for preparation and storage, then record the results according to the control protocol in your laboratory.
The purpose of Liquichek Tumor Markers Control is to provide laboratories with a standardized reference material to verify the accuracy and reliability of tumor marker assays.
Laboratories must report the control values, any deviations from expected results, and the calibration status as part of the quality control documentation for Liquichek Tumor Markers Control.
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Bio-Rad Laboratories Tumor Markers Control premarket notification 510(k) quality control material clinical chemistry laboratory testing FDA

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