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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. 510 k Number if known Device Name EUROIMMUN Anti-Borrelia burgdorferi US Westernblot IgG The EUROIMMUN Anti-Borrelia burgdorferi US Westernblot IgG kit is a Western blot assay intended for the qualitative determination of IgG class antibodies against Borrelia burgdorferi in human serum and plasma K -EDTA Li - Na -citrate...

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How to fill out anti-borrelia burgdorferi us westernblot

01

Step 1: Obtain the anti-borrelia burgdorferi US Westernblot kit.

02

Step 2: Read the instructions carefully to familiarize yourself with the procedure.

03

Step 3: Prepare the necessary materials, including the test kit, sample, and reagents.

04

Step 4: Take the test kit out of the packaging and place it on a clean and flat surface.

05

Step 5: Label the provided sample tubes with the appropriate patient information.

06

Step 6: Collect the sample according to the guidelines provided.

07

Step 7: Transfer the collected sample into the labeled sample tubes.

08

Step 8: Add the specified reagents to the sample tubes as instructed.

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Step 9: Mix the contents of the sample tubes gently by inverting them several times.

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Step 10: Place the tubes in a centrifuge and spin them at the recommended speed and duration.

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Step 11: Carefully remove the tubes from the centrifuge and discard the supernatant.

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Step 12: Transfer the sediment to a clean tube using a pipette.

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Step 13: Add the provided buffer solution to the tube containing the sediment.

14

Step 14: Cap the tube and shake it gently to ensure proper mixing of the contents.

15

Step 15: Place the tube in a water bath or heat block at the specified temperature.

16

Step 16: Incubate the tube for the recommended duration.

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Step 17: Remove the tube from the water bath and let it cool down to room temperature.

18

Step 18: Transfer the contents of the tube to the provided test plate.

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Step 19: Incubate the test plate at the specified temperature for the specified time.

20

Step 20: Carefully read the results and interpret them according to the guidelines.

Who needs anti-borrelia burgdorferi us westernblot?

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Individuals who exhibit symptoms associated with Lyme disease, such as fatigue, joint pain, muscle aches, and fever, may need to undergo anti-borrelia burgdorferi US Westernblot testing.

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Patients who have been exposed to tick bites in areas known to have a high prevalence of Lyme disease should consider getting tested.

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Those who have previously received positive results on other Lyme disease screening tests, such as the enzyme immunoassay (EIA), may need to confirm the diagnosis with an anti-borrelia burgdorferi US Westernblot.

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Individuals with a medical history or clinical presentation suggesting Lyme disease should consult with a healthcare professional who can determine the necessity of anti-borrelia burgdorferi US Westernblot testing.

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