Phadebact Monoclonal GC Test

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

510(k) Number

K850351 ↗

FDA Product Code

LIC

Device Class

Class II

Regulation

21 CFR Part 866.3390

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the Phadebact Monoclonal GC Test used for?

  The Phadebact Monoclonal GC Test is used for the identification of Neisseria gonorrhoeae in microbiology laboratories. It is an antiserum-based coagglutination (direct) test designed specifically for this purpose, as stated in the device description.

• How is the Phadebact Monoclonal GC Test supplied and what is its intended use setting?

  The test is supplied as an antiserum-based coagglutination reagent intended for use in microbiology laboratories. It is designed for laboratory professionals to identify Neisseria gonorrhoeae from clinical specimens, not for point-of-care or over-the-counter use.

• Is the Phadebact Monoclonal GC Test a single-use or reusable device?

  The Phadebact Monoclonal GC Test is a single-use in vitro diagnostic reagent. As an antiserum-based test, it is consumed during the agglutination reaction and cannot be reused, which is standard for such microbiological identification reagents.