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*Ionosphere 510(K) Summary 2 0 2014The Summary for this 5 10(k) submission is submitted in accordance with the requirements of SODA 1900 and CFR 807.92 510(k) Number: K140083:Perigee Enteric Pathogens
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How to fill out verigene enteric pathogens test

01
Begin by collecting a stool sample from the patient. Make sure to use a sterile container and follow proper hygiene procedures.
02
Label the container with the patient's information, including name, date of collection, and any other relevant details.
03
Prepare the Verigene Enteric Pathogens Test kit according to the manufacturer's instructions.
04
Transfer a small amount of stool sample into the provided sample lysis tube. Follow the recommended volume mentioned in the kit instructions.
05
Add the necessary reagents and mix well by inverting the tube several times.
06
Place the tube in the Verigene System and follow the device's instructions to initiate the test.
07
The Verigene System will perform the necessary analysis and provide the results once the test is complete.
08
Interpret the results based on the provided guidelines and consult with a healthcare professional if needed.
09
Dispose of the used materials and sanitize the work area to maintain cleanliness and prevent contamination.

Who needs verigene enteric pathogens test?

01
The Verigene Enteric Pathogens Test is typically recommended for individuals who present with symptoms of gastrointestinal infection such as diarrhea, abdominal pain, vomiting, and fever.
02
It is particularly useful for patients who have a suspected enteric infection or when there is a concern about outbreaks or the need for targeted therapy.
03
Healthcare providers may also order this test for patients with a compromised immune system, travelers with potential exposure to enteric pathogens, or individuals at high risk for foodborne illnesses.
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Verigene enteric pathogens test is a molecular diagnostic test that detects gastrointestinal pathogens such as bacteria, viruses, and parasites.
Verigene enteric pathogens test is typically performed by healthcare providers in a clinical setting.
To fill out verigene enteric pathogens test, follow the instructions provided by the testing laboratory or manufacturer.
The purpose of verigene enteric pathogens test is to identify the causative agents of gastrointestinal infections.
The test results, including the pathogens detected and their relative quantities, should be reported on verigene enteric pathogens test.
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