Company ยท US
OraSure Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2019. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (0 in 12 months)
14recalls (0 in 12 months)
12recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 9 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 6 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 5 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 4 |
| DIS | Enzyme Immunoassay, Barbiturate | 3 |
| MKU | Enzyme Immunoassay, Nicotine And Nicotine Metabolites | 3 |
| DJG | Enzyme Immunoassay, Opiates | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | 2 |
| LAF | Gas Chromatography, Methamphetamine | 2 |
| LCM | Enzyme Immunoassay, Phencyclidine | 2 |
| CFR | Hexokinase, Glucose | 1 |
| DJR | Enzyme Immunoassay, Methadone | 1 |
| MZO | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | 1 |
| PJD | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device | 1 |
| QID | Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 10, 2019 | DEN190025 | OraQuick Ebola Rapid Antigen Test OraSure Technologies, Inc. | QID |
| Jul 18, 2006 | K060859 | COMPOUND W FREEZE OFF WART REMOVAL SYSTEM OraSure Technologies, Inc. | GEH |
| Mar 20, 2003 | K023487 | HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME OraSure Technologies, Inc. | GEH |
| Apr 17, 2002 | K013882 | OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I OraSure Technologies, Inc. | JXM |
| Apr 3, 2002 | K020371 | UPLINK TEST SYSTEM OraSure Technologies, Inc. | DJG |
| Jun 6, 2001 | K011057 | INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX OraSure Technologies, Inc. | PJD |
| Jan 26, 2001 | K002375 | STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I OraSure Technologies, Inc. | LDJ |
| Dec 6, 2000 | K001976 | STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I OraSure Technologies, Inc. | DIS |
| Nov 29, 2000 | K002010 | STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 OraSure Technologies, Inc. | DJR |
| May 15, 2000 | K000399 | STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 OraSure Technologies, Inc. | LCM |
| May 11, 2000 | K001197 | COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA OraSure Technologies, Inc. | DIO |
| Apr 3, 2000 | K993208 | STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I OraSure Technologies, Inc. | LAF |
| Apr 3, 2000 | K992918 | STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I OraSure Technologies, Inc. | DKZ |
| Jun 14, 1999 | K990877 | HISTOFREEZER DEVICE OraSure Technologies, Inc. | GEH |
| Nov 20, 1998 | K982759 | AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U OraSure Technologies, Inc. | DIO |
| Nov 18, 1998 | K982745 | AUTO-LYTE BARBITURATES EIA OraSure Technologies, Inc. | DIS |
| Nov 12, 1998 | K982831 | AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U OraSure Technologies, Inc. | JXM |
| Nov 4, 1998 | K982801 | AUTO-LYTE PCP EIA, MODEL #1254U OraSure Technologies, Inc. | LCM |
| Oct 2, 1998 | K982358 | HISTOFREEZER DEVICE OraSure Technologies, Inc. | GEH |
| Aug 25, 1998 | K982061 | STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) OraSure Technologies, Inc. | DIO |
| May 26, 1998 | K980739 | HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS OraSure Technologies, Inc. | GEH |
| May 22, 1998 | K981341 | STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) OraSure Technologies, Inc. | DJG |
| May 18, 1998 | K974534 | MICRO-PLATE COTININE EIA OraSure Technologies, Inc. | MKU |
| May 14, 1998 | K974234 | MICRO-PLATE COTININE EIA OraSure Technologies, Inc. | MKU |
| Feb 13, 1998 | K973750 | STC CANNABINOIDS MICRO-PLATE EIA OraSure Technologies, Inc. | LDJ |
| Jan 28, 1998 | K972989 | STC METHAMPHETAMINE MICRO-PLATE EIA OraSure Technologies, Inc. | DKZ |
| Jan 2, 1998 | K973651 | STC COCAINE METABOLITE MICRO-PLATE EIA OraSure Technologies, Inc. | DIO |
| Oct 21, 1997 | K972481 | AUTO-LYTE COTININE EIA OraSure Technologies, Inc. | MKU |
| Oct 21, 1997 | K971392 | HISTOFREEZER VERRUCA PLANA OraSure Technologies, Inc. | GEH |
| Dec 26, 1996 | K962435 | STC AUTO-LYTE URINARY GLUCOSE ASSAY OraSure Technologies, Inc. | CFR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2021 | OraSure Technologies, Inc. Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C. Terminated |
LAF | K993208 |
| Jul 15, 2020 | OraSure Technologies, Inc. Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil
Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags. Terminated |
GEH | K023487 |
| Jul 15, 2020 | OraSure Technologies, Inc. Personelle OTC Skin Tag Remover, Canada
Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags. Terminated |
GEH | K023487 |
| Jul 15, 2020 | OraSure Technologies, Inc. CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts. Terminated |
GEH | K023487 |
| Jul 13, 2020 | OraSure Technologies, Inc. Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT Terminated |
JXM | K013882 |
| Jul 13, 2020 | OraSure Technologies, Inc. Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB Terminated |
JXM | K013882 |
| Dec 20, 2017 | OraSure Technologies, Inc. Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000 Terminated |
DIO | K982061 |
| Dec 8, 2016 | OraSure Technologies, Inc. Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate)
Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids. Terminated |
DIS | K001976 |
| Aug 17, 2016 | OraSure Technologies, Inc. OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses. Terminated |
None listed | |
| Jan 15, 2016 | OraSure Technologies, Inc. OraQuick HCV Visual Reference Panel
Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device. Terminated |
MZO | None listed |
| Dec 23, 2008 | OraSure Technologies, Inc. Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro Plate EIA kit. Terminated |
LDJ | K002375 |
| Dec 23, 2008 | OraSure Technologies, Inc. Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro Plate EIA kit. Terminated |
LDJ | K002375 |
| Dec 23, 2008 | OraSure Technologies, Inc. Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro Plate EIA kit. Terminated |
LDJ | K002375 |
| Dec 18, 2008 | OraSure Technologies, Inc. Cannabinoids Intercept Micro Plate EIA 100 plate kit Terminated |
LDJ | K002375 |