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PJD — Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device Class II

FDA Device Classification

Classification Details

Product Code
PJD
Device Class
Class II
Regulation Number
862.1675
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Definition

Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232898immunalysis corporationQuantisal™ Oral Fluid Collection DeviceNovember 21, 2023
K223781immunalysis corporationQuantisal™ II Oral Fluid Collection DeviceJuly 28, 2023
K200801immunalysis corporationQuantisal Oral Fluid Collection DeviceJuly 28, 2020
K183048immunalysis corporationQuantisal II Oral Fluid Collection DeviceJuly 29, 2019
K011057orasure technologiesINTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXXJune 6, 2001
K984361osborn laboratoriesORAL-EZE ORAL FLUID COLLECTION SYSTEMJanuary 13, 1999
K973395epitopeEPISCREEN ORAL SPECIMEN COLLECTION DEVICEFebruary 13, 1998
K970357epitopeEPISCREENMarch 10, 1997
K942435saliva diagnostic systemsSALIVA SAMPLERAugust 21, 1995