OraSure Technologies, Inc.
FDA 510(k) medical device clearances.
Top product codes for OraSure Technologies, Inc.
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.