DeviceClearance

Product code PTH— Clinical Toxicology

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

Classification name
Test, Barbiturate, Over The Counter
Device class
Class 2
Regulation
21 CFR 862.3150
Advisory panel
Clinical Toxicology
Total cleared
1
First cleared
Most recent

FDA classification definition

“The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates in human urine.”

— U.S. Food and Drug Administration, device classification record for product code PTH under 21 CFR 862.3150, via openFDA

Market context for product code PTH

FDA has cleared 1 device under product code PTH, all in 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PTH

Recent clearances under product code PTH

Data sourced from openFDA. This site is unofficial and independent of the FDA.