OraSure Technologies, Inc.
Medical device manufacturer in Bethlehem, PA.
29510(k) clearances
1PMA approvals
14recalls
Device types
- GEH Unit, Cryosurgical, Accessories 6
- DIO Enzyme Immunoassay, Cocaine And Cocaine… 4
- MKU Enzyme Immunoassay, Nicotine And Nicotine… 3
- DKZ Enzyme Immunoassay, Amphetamine 2
- LDJ Enzyme Immunoassay, Cannabinoids 2
- DJG Enzyme Immunoassay, Opiates 2
- LCM Enzyme Immunoassay, Phencyclidine 2
- JXM Enzyme Immunoassay, Benzodiazepine 2
- DIS Enzyme Immunoassay, Barbiturate 2
- CFR Hexokinase, Glucose 1
- LAF Gas Chromatography, Methamphetamine 1
- DJR Enzyme Immunoassay, Methadone 1
- PJD Oral Fluid Drugs Of Abuse And Alcohol Test… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K060859 | Compound W Freeze Off Wart Removal SystemGEH · Special | 07/18/2006SE |
| K023487 | Histofreezer Wart Removal System or Other Proprietary NameGEH · Traditional | 03/20/2003SE |
| K013882 | Oti Benzodiazepines Intercept Micro-Plate Eia Model #1110IJXM · Traditional | 04/17/2002SE |
| K020371 | Uplink Test SystemDJG · Traditional | 04/03/2002SE |
| K011057 | Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXXPJD · Traditional | 06/06/2001SE |
| K002375 | STC Cannabinoids Intercept Micro-Plate Eia, Model 1118ILDJ · Traditional | 01/26/2001SE |
| K001976 | STC Barbiturates Intercept Micro-Plate Eia, Model 1108IDIS · Traditional | 12/06/2000SE |
| K002010 | STC Methadone Intercept Micro-Plate Eia, Model 11421DJR · Traditional | 11/29/2000SE |
| K000399 | STC PCP Intercept Micro-Plate Eia, Model 11541LCM · Traditional | 05/15/2000SE |
| K001197 | Cocaine Metabolite Intercept Micro-Plate EiaDIO · Special | 05/11/2000SE |
| K993208 | STC Methamphetamine Intercept Micro-Plate Eia, Model 1104ILAF · Traditional | 04/03/2000SE |
| K992918 | STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103IDKZ · Traditional | 04/03/2000SE |
| K990877 | Histofreezer DeviceGEH · Traditional | 06/14/1999SE |
| K982759 | Auto-Lyte Cocaine Metabolite Eia, Model # 1222UDIO · Traditional | 11/20/1998SE |
| K982745 | Auto-Lyte Barbiturates EiaDIS · Traditional | 11/18/1998SE |
| K982831 | Auto-Lyte Benzodiazepines Eia Model Number 1210UJXM · Traditional | 11/12/1998SE |
| K982801 | Auto-Lyte PCP Eia, Model #1254ULCM · Traditional | 11/04/1998SE |
| K982358 | Histofreezer DeviceGEH · Traditional | 10/02/1998SE |
| K982061 | STC Cocaine Metabolite Micro-Plate Eia (Orasure Device)DIO · Traditional | 08/25/1998SE |
| K980739 | Histofreezer/ 17% Salicylic Acid-Verruca PlantarisGEH · Traditional | 05/26/1998SE |
| K981341 | STC Opiates Micro-Plate Eia (Orasure Application)DJG · Traditional | 05/22/1998SE |
| K974534 | Micro-Plate Cotinine EiaMKU · Traditional | 05/18/1998SE |
| K974234 | Micro-Plate Cotinine EiaMKU · Traditional | 05/14/1998SE |
| K973750 | STC Cannabinoids Micro-Plate EiaLDJ · Traditional | 02/13/1998SE |
| K972989 | STC Methamphetamine Micro-Plate EiaDKZ · Traditional | 01/28/1998SE |
| K973651 | STC Cocaine Metabolite Micro-Plate EiaDIO · Traditional | 01/02/1998SE |
| K972481 | Auto-Lyte Cotinine EiaMKU · Traditional | 10/21/1997SE |
| K971392 | Histofreezer Verruca PlanaGEH · Traditional | 10/21/1997SE |
| K962435 | STC Auto-Lyte Urinary Glucose AssayCFR · Traditional | 12/26/1996SE |
PMA approvals
- P080027 Oraquick HCV Rapid Antibody Test · 06/25/2010 · 35 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1183-2021 Class III | Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of…Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the… | 02/05/2021Terminated |
| Z-3003-2020 Class III | Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 -…Unit boxes not properly sealed | 07/15/2020Terminated |
| Z-3002-2020 Class III | Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage:…Unit boxes not properly sealed | 07/15/2020Terminated |
| Z-3001-2020 Class III | CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for…Unit boxes not properly sealed | 07/15/2020Terminated |
| Z-2877-2020 Class III | Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix…Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit… | 07/13/2020Terminated |
| Z-2876-2020 Class III | Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral…Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit… | 07/13/2020Terminated |
| Z-1419-2018 Class III | Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI:…The controls and calibrators contained within the cocaine test kit may cause false positive results with the… | 12/20/2017Terminated |
| Z-0722-2017 Class III | Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is…Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect… | 11/10/2016Terminated |
| Z-2403-2016 Class I | OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative…Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive… | 07/20/2016Terminated |
| Z-1509-2016 Class III | OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming…OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test… | 01/15/2016Terminated |
| Z-0481-2009 | Cannabinoids Intercept Micro Plate EIA 100 plate kitReadings, high: intermittent high absorbance readings. For further information, please contact the firm at… | 09/08/2008Terminated |
| Z-0479-2009 | Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro…Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information… | 09/08/2008Terminated |
| Z-0478-2009 | Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro…Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information… | 09/08/2008Terminated |
| Z-0477-2009 | Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro…Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information… | 09/08/2008Terminated |