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Gonodecten

by Mediserve International, Inc.

PMA P770010

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P770010↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP770010 Date10 Jun 1980ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
TEST REAGENTS, NEISSERIA GONORRHOEAE BIOCHEMICAL
PMA Number
FDA Product Code
LTS
Device Class
Class I
Regulation
21 CFR Part 866.2660
Advisory Committee
Microbiology
FDA Decision
APPR Approved
PMA Supplement
S001

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a biochemical test reagent designed for the identification of Neisseria gonorrhoeae bacteria, classified under the nomenclature authority as Test Reagents, Neisseria Gonorrhoeae Biochemical. It employs biochemical assays to detect specific metabolic or enzymatic characteristics of the organism, aiding in microbiological diagnosis of gonorrhea infections.

The reagent is supplied as a sterile, single-use diagnostic tool intended for use in microbiology laboratories. It adheres to FDA Premarket Approval (PMA) requirements under regulation number 866.2660, with product code LTS. Storage conditions and handling must comply with standard microbiological practices to maintain sterility and efficacy, though specific details are not provided in the data.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the GONODECTEN reagent used for in a clinical setting?

    The GONODECTEN reagent is a biochemical test designed specifically to identify *Neisseria gonorrhoeae* bacteria in microbiology laboratories. It works by detecting unique metabolic or enzymatic traits of the organism, helping confirm gonorrhea infections through laboratory testing.

  • Is the GONODECTEN reagent single-use or reusable, and how should it be stored?

    The GONODECTEN reagent is supplied as a sterile, single-use diagnostic tool. While specific storage instructions aren’t detailed, standard microbiological practices must be followed to preserve sterility and ensure the reagent remains effective for its intended biochemical assays.

  • What regulatory pathway was followed for the approval of the GONODECTEN reagent?

    The GONODECTEN reagent received FDA Premarket Approval (PMA) under regulation number 866.2660, with the product code LTS. This approval process was completed on June 10, 1980, as documented in the PMA file number P770010.

  • What type of laboratory setting is the GONODECTEN reagent intended for?

    The GONODECTEN reagent is classified under microbiology and is intended exclusively for use in microbiology laboratories. Its biochemical assay design requires specialized laboratory conditions to accurately detect *Neisseria gonorrhoeae* through metabolic or enzymatic analysis.