OraSure Technologies, Inc.
Bethlehem, PA, US
ORASURE TECHNOLOGIES, INC. appears in FDA device records in Bethlehem, PA. FDA records list 30 510(k) clearances between and , 36 PMA records and 3 registered establishments. As of , FDA records show 14 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 30 510(k) clearances for OraSure Technologies, Inc. between 1996 and 2019. The busiest year on record is 1998, with 13. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 13 |
| 1999 | 1 |
| 2000 | 6 |
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 1 |
| 2006 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| DEN190025 | OraQuick Ebola Rapid Antigen Test | QID | Unknown | |
| K060859 | COMPOUND W FREEZE OFF WART REMOVAL SYSTEM | GEH | Substantially Equivalent | |
| K023487 | HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME | GEH | Substantially Equivalent | |
| K013882 | OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I | JXM | Substantially Equivalent | |
| K020371 | UPLINK TEST SYSTEM | DJG | Substantially Equivalent | |
| K011057 | INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX | PJD | Substantially Equivalent | |
| K002375 | STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I | LDJ | Substantially Equivalent | |
| K001976 | STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I | DIS | Substantially Equivalent | |
| K002010 | STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 | DJR | Substantially Equivalent | |
| K000399 | STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 | LCM | Substantially Equivalent | |
| K001197 | COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA | DIO | Substantially Equivalent | |
| K993208 | STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I | LAF | Substantially Equivalent | |
| K992918 | STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I | DKZ | Substantially Equivalent | |
| K990877 | HISTOFREEZER DEVICE | GEH | Substantially Equivalent | |
| K982759 | AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U | DIO | Substantially Equivalent | |
| K982745 | AUTO-LYTE BARBITURATES EIA | DIS | Substantially Equivalent | |
| K982831 | AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U | JXM | Substantially Equivalent | |
| K982801 | AUTO-LYTE PCP EIA, MODEL #1254U | LCM | Substantially Equivalent | |
| K982358 | HISTOFREEZER DEVICE | GEH | Substantially Equivalent | |
| K982061 | STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) | DIO | Substantially Equivalent | |
| K980739 | HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS | GEH | Substantially Equivalent | |
| K981341 | STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) | DJG | Substantially Equivalent | |
| K974534 | MICRO-PLATE COTININE EIA | MKU | Substantially Equivalent | |
| K974234 | MICRO-PLATE COTININE EIA | MKU | Substantially Equivalent | |
| K973750 | STC CANNABINOIDS MICRO-PLATE EIA | LDJ | Substantially Equivalent | |
| K972989 | STC METHAMPHETAMINE MICRO-PLATE EIA | DKZ | Substantially Equivalent | |
| K973651 | STC COCAINE METABOLITE MICRO-PLATE EIA | DIO | Substantially Equivalent | |
| K972481 | AUTO-LYTE COTININE EIA | MKU | Substantially Equivalent | |
| K971392 | HISTOFREEZER VERRUCA PLANA | GEH | Substantially Equivalent | |
| K962435 | STC AUTO-LYTE URINARY GLUCOSE ASSAY | CFR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004142665 | 3004142665 | ORASURE TECHNOLOGIES INC. | 220 EAST FIRST STREET, BETHLEHEM, PA 18015 US | 2026 | |
| 3003297763 | 3003297763 | ORASURE TECHNOLOGIES, INC. | 150 WEBSTER ST, Bethlehem, PA 18015 US | 2026 | |
| 3022474803 | 3022474803 | ORASURE TECHNOLOGIES, INC. | 2685 Opus Way, Bethlehem, PA 18020 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MZOAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- QKPCoronavirus Antigen Detection Test System.
- SIHDevice For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay
- QIDDevice To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
- QPODevice To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
- LIODevice, Specimen Collection
- OYJDna Specimen Collection, Saliva
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- LAFGas Chromatography, Methamphetamine
- CFRHexokinase, Glucose
- QSSHiv Self-Tests
- PJDOral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
- QSUPoint Of Care Hiv Serology Diagnostic And/Or Supplemental Test
- POGReagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid
- OTVResearch Use Only/Clinical Chemistry Devices
- OTTResearch Use Only/Microbiology
- GEHUnit, Cryosurgical, Accessories
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1183-2021 | Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C. | Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained Substrate Reagent (TMB) lot 6679623, should not affect performance. | Class III | Terminated | |
| Z-3003-2020 | 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. | Unit boxes not properly sealed | Class III | Terminated | |
| Z-3002-2020 | 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. | Unit boxes not properly sealed | Class III | Terminated | |
| Z-3001-2020 | 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. | Unit boxes not properly sealed | Class III | Terminated | |
| Z-2877-2020 | Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT | Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box | Class III | Terminated | |
| Z-2876-2020 | Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB | Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box | Class III | Terminated | |
| Z-1419-2018 | Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000 | The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control. | Class III | Terminated | |
| Z-0722-2017 | 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. | Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing. | Class III | Terminated | |
| Z-2403-2016 | OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses. | Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions. | Class I | Terminated | |
| Z-1509-2016 | 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. | OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a complaint received from one of their customers. The customer reported they received the Ora Quick Ebola Visual Reference Panel instead of an OraQuick HCV Visual Reference Panel. | Class III | Terminated | |
| Z-0481-2009 | Cannabinoids Intercept Micro Plate EIA 100 plate kit | Readings, high: intermittent high absorbance readings. For further information, please contact the firm at 610-882-1820. | Terminated | ||
| Z-0479-2009 | Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro Plate EIA kit. | Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820. | Terminated | ||
| Z-0478-2009 | Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro Plate EIA kit. | Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820. | Terminated | ||
| Z-0477-2009 | Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro Plate EIA kit. | Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain