Phadebas Rast Peniclloyl G/V Test

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K771578 ↗

FDA Product Code

DHB

Device Class

Class II

Regulation

21 CFR Part 866.5750

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What is the Phadebas RAST Penicilloyl G/V Test used for?

  This test is designed for in vitro detection of specific immunoglobulin E (IgE) antibodies against penicilloyl G and V determinants in serum samples. By quantifying IgE binding to penicillin conjugates, it helps clinicians diagnose allergic sensitivity to penicillin, supporting accurate allergy assessment in clinical immunology settings.

• How is the Phadebas RAST Penicilloyl G/V Test supplied and intended for use?

  The test is supplied as a kit for laboratory use only. Each kit is intended for single-use per manufacturer specifications, requiring sterile handling to ensure accurate and reliable results. It is not intended for reuse or alternative clinical environments outside of controlled laboratory settings.

• Is sterility a requirement for this test kit?

  Yes, the Phadebas RAST Penicilloyl G/V Test must be handled under sterile conditions due to its classification as an immunological diagnostic device. Sterility is critical to prevent contamination and ensure the integrity of the assay results, which measure IgE binding to penicillin determinants.

• What regulatory approval does this device hold?

  The Phadebas RAST Penicilloyl G/V Test holds FDA 510(k) clearance under the reference number K771578, classified as a Class II device. This clearance confirms its substantial equivalence to a predicate device and authorizes commercial distribution in the United States for its intended use in clinical immunology.

• Are there any special storage or handling instructions provided for this test?

  While specific storage conditions are not detailed in the provided data, standard laboratory protocols for immunological assays should be followed. This includes maintaining appropriate temperature, humidity, and protection from light to preserve the test kit’s stability and performance until use. Always adhere to manufacturer guidelines for optimal results.