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 In this section:

        In Vitro Diagnostics

Tests Used In Clinical Care

                        
                Safety Issue on Magellan Diagnostics LeadCare Testing Systems Home
          Medical Devices
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          In Vitro Diagnostics
          Tests Used In Clinical CareIn Vitro Diagnostics Tests Used In Clinical Care
  	
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    Print**What are lab tests?**
Laboratory tests are medical devices that are intended for use on samples of blood, urine, or other tissues or substances taken from the body to help diagnose disease or other conditions.

**Why does your doctor use lab tests?**
Your doctor uses laboratory tests to help:

identify changes in your health condition before any symptoms occur
	diagnose or aid in diagnosing a disease or condition,
	plan your treatment for a disease or condition,
	evaluate your response to a treatment, or
	monitor the course of a disease over time.**How are lab tests analyzed?**
After your doctor collects a sample from your body, it is sent to a laboratory. Laboratories perform tests on the sample to see if it contains different substances, and how much. Depending on the test, the presence, absence, or amount of an analyte may mean you do have a particular condition or it may mean that you do not have the particular condition. Sometimes laboratories compare your results to results obtained from previous tests, to see if there has been a change in your condition.

**What do lab tests show?**
Some types of lab tests show whether or not your results fall within normal ranges. Normal test values are usually given as a range, rather than as a specific number, because normal values vary from person to person. What is normal for one person may not be normal for another person.

Other types show whether there is a particular substance present or absent, such as a mutation in a gene, or an infectious organism, which indicates whether you have a disease, an infection, or may or may not respond to a therapy.

Some laboratory tests are precise, reliable indicators of specific health problems, while others provide more general information that gives doctors clues to your possible health problems. Information obtained from laboratory tests may help doctors decide whether other tests or procedures are needed to make a diagnosis or to develop or revise a previous treatment plan. All laboratory test results must be interpreted within the context of your overall health and should be used along with other exams or tests.

**What factors affect your lab test results?**
Many factors can affect test results, including:

sex
	age
	race
	medical history
	general health
	specific foods
	drugs you are taking
	how closely your follow preparatory instructions
	variations in laboratory techniques
	variation from one laboratory to anotherUseful Links

Find All FDA-Approved Home and Lab Tests
	Find All In Vitro Diagnostic Products and Decision Summaries Since November 2003
	Home Use Tests: Glossary
	Lab Tests Online

                                                                                  Content current as of:
      09/27/2018
                  
                   
Regulated Product(s)
		 Medical DevicesTests Used In Clinical Care                
                          

                        Safety Issue on Magellan Diagnostics LeadCare Testing Systems
 
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