PTGClass II

Test, Methadone, Over The Counter

21 CFR 862.3620 / Clinical Toxicology

PTG is the FDA product code for Test, Methadone, Over The Counter, a class II device type, regulated under 21 CFR 862.3620. FDA's definition for this code reads: "The methadone test is an in vitro diagnostic test for the qualitative analysis of methadone in human urine". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PTG
Device name: Test, Methadone, Over The Counter
FDA definition: The methadone test is an in vitro diagnostic test for the qualitative analysis of methadone in human urine.
Regulation: 21 CFR 862.3620
Device class: Class II
Review panel: Clinical Toxicology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 53 companies shown, in name order

Recent clearances

Product code PTG

FDA records hold no clearances under product code PTG.

Recent recalls

Product code PTG

FDA records show no recalls under product code PTG.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)