OraSure Technologies, Inc.
FDA Regulatory Profile
OraSure Technologies, Inc. appears in FDA public data with 10 recalls — including 1 Class I (most serious) —, 30 510(k) clearances, 14 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1183-2021, Class III) was initiated on February 5, 2021. Its most recent 510(k) clearance was granted on October 10, 2019.
Summary
- Total Recalls
- 10 (1 Class I)
- 510(k) Clearances
- 30
- Inspections
- 14
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1183-2021 | Class III | Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in o | February 5, 2021 |
| Z-3002-2020 | Class III | Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for o | July 15, 2020 |
| Z-3001-2020 | Class III | CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-cou | July 15, 2020 |
| Z-3003-2020 | Class III | Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: | July 15, 2020 |
| Z-2877-2020 | Class III | Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coat | July 13, 2020 |
| Z-2876-2020 | Class III | Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coate | July 13, 2020 |
| Z-1419-2018 | Class III | Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000 | December 20, 2017 |
| Z-0722-2017 | Class III | Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for | November 10, 2016 |
| Z-2403-2016 | Class I | OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection | July 20, 2016 |
| Z-1509-2016 | Class III | OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at r | January 15, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN190025 | OraQuick Ebola Rapid Antigen Test | October 10, 2019 |
| K060859 | COMPOUND W FREEZE OFF WART REMOVAL SYSTEM | July 18, 2006 |
| K023487 | HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME | March 20, 2003 |
| K013882 | OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I | April 17, 2002 |
| K020371 | UPLINK TEST SYSTEM | April 3, 2002 |
| K011057 | INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX | June 6, 2001 |
| K002375 | STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I | January 26, 2001 |
| K001976 | STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I | December 6, 2000 |
| K002010 | STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 | November 29, 2000 |
| K000399 | STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 | May 15, 2000 |
| K001197 | COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA | May 11, 2000 |
| K993208 | STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I | April 3, 2000 |
| K992918 | STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I | April 3, 2000 |
| K990877 | HISTOFREEZER DEVICE | June 14, 1999 |
| K982759 | AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U | November 20, 1998 |
| K982745 | AUTO-LYTE BARBITURATES EIA | November 18, 1998 |
| K982831 | AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U | November 12, 1998 |
| K982801 | AUTO-LYTE PCP EIA, MODEL #1254U | November 4, 1998 |
| K982358 | HISTOFREEZER DEVICE | October 2, 1998 |
| K982061 | STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) | August 25, 1998 |