Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Clinical Chemistry · 21 CFR 862.1675
Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.
Recent MDR events
11 adverse event reports on file
- QUANTISAL DRUG TESTApr 14, 2025InjuryUnknownMW5169013
- QUANTISAL SALIVA COLLECTION DEVICESJun 25, 2024MalfunctionStatsure Diagnostic Systems3008264082-2024-00001
- QUANTISALSep 4, 2023InjuryStatsure Diagnostic Systems3008264082-2023-00001
- INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICEJul 25, 2023InjuryOrasure Technologies, Inc.3004142665-2023-00021
- QUANTISALApr 13, 2022InjuryStatsure Diagnostic Systems3008264082-2022-00001
- QUANTISALDec 21, 2020InjuryStatsure Diagnostic Systems3008264082-2020-00001
- ORAL EZE ORAL FLUID COLLECTION SYSTEMSep 24, 2020InjuryMicrogenics Corporation3010939897-2020-00001
- INTERCEPTSep 17, 2020InjuryOrasure Technologies Inc.3004142665-2020-00005
- INTERCEPTMar 5, 2019InjuryOrasure Technologies Inc3004142665-2019-00002
- ORAL-EZE ORAL FLUID COLLECTORAug 17, 2017InjuryMicrogenics Corporation3010939897-2017-00001
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
7 firms currently registered for this product code
510(k) clearances
9 clearances for this product code
- Immunalysis CorporationNov 21, 2023
K232898 · Quantisal Oral Fluid Collection Device
- Immunalysis CorporationJul 28, 2023
K223781 · Quantisal II Oral Fluid Collection Device
- Immunalysis CorporationJul 28, 2020
K200801 · Quantisal Oral Fluid Collection Device
- Immunalysis CorporationJul 29, 2019
K183048 · Quantisal II Oral Fluid Collection Device
- OraSure Technologies, Inc.Jun 6, 2001
K011057 · INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
- Osborn Laboratories, Inc.Jan 13, 1999
K984361 · ORAL-EZE ORAL FLUID COLLECTION SYSTEM
- Epitope, Inc.Feb 13, 1998
K973395 · EPISCREEN ORAL SPECIMEN COLLECTION DEVICE
- Epitope, Inc.Mar 10, 1997
K970357 · EPISCREEN