OraSure Technologies, Inc.
OraSure Technologies, Inc. holds FDA 510(k) medical device clearances, first cleared 1996, most recent 2019, with 10 FDA device recalls on record.
Top product codes for OraSure Technologies, Inc.
FDA recalls by OraSure Technologies, Inc.
- Z-1183-2021 — Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
- 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.
- 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.
- 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.
- 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
- 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
- Z-1419-2018 — Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
- 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.
- Z-2403-2016 — OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by OraSure Technologies, Inc.
- DEN190025 — OraQuick Ebola Rapid Antigen Test
- K060859 — COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
- K023487 — HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
- K013882 — OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
- K020371 — UPLINK TEST SYSTEM
- K011057 — INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
- K002375 — STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
- K001976 — STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
- K002010 — STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
- K000399 — STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
- K001197 — COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
- K992918 — STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I
- K993208 — STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I
- K990877 — HISTOFREEZER DEVICE
- K982759 — AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U
- K982745 — AUTO-LYTE BARBITURATES EIA
- K982831 — AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
- K982801 — AUTO-LYTE PCP EIA, MODEL #1254U
- K982358 — HISTOFREEZER DEVICE
- K982061 — STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)
- K980739 — HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS
- K981341 — STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)
- K974534 — MICRO-PLATE COTININE EIA
- K974234 — MICRO-PLATE COTININE EIA
- K973750 — STC CANNABINOIDS MICRO-PLATE EIA
- K972989 — STC METHAMPHETAMINE MICRO-PLATE EIA
- K973651 — STC COCAINE METABOLITE MICRO-PLATE EIA
- K971392 — HISTOFREEZER VERRUCA PLANA
- K972481 — AUTO-LYTE COTININE EIA
- K962435 — STC AUTO-LYTE URINARY GLUCOSE ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.