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OraSure Technologies, Inc.

30 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
OraQuick Ebola Rapid Antigen Test (DEN190025)OraSure Technologies, Inc.2019-10-10
COMPOUND W FREEZE OFF WART REMOVAL SYSTEM (K060859)OraSure Technologies, Inc.2006-07-18
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME (K023487)OraSure Technologies, Inc.2003-03-20
OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I (K013882)OraSure Technologies, Inc.2002-04-17
UPLINK TEST SYSTEM (K020371)OraSure Technologies, Inc.2002-04-03
INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX (K011057)OraSure Technologies, Inc.2001-06-06
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I (K002375)OraSure Technologies, Inc.2001-01-26
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I (K001976)OraSure Technologies, Inc.2000-12-06
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 (K002010)OraSure Technologies, Inc.2000-11-29
STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 (K000399)OraSure Technologies, Inc.2000-05-15
COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA (K001197)OraSure Technologies, Inc.2000-05-11
STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I (K993208)OraSure Technologies, Inc.2000-04-03
STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I (K992918)OraSure Technologies, Inc.2000-04-03
HISTOFREEZER DEVICE (K990877)OraSure Technologies, Inc.1999-06-14
AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U (K982759)OraSure Technologies, Inc.1998-11-20
AUTO-LYTE BARBITURATES EIA (K982745)OraSure Technologies, Inc.1998-11-18
AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U (K982831)OraSure Technologies, Inc.1998-11-12
AUTO-LYTE PCP EIA, MODEL #1254U (K982801)OraSure Technologies, Inc.1998-11-04
HISTOFREEZER DEVICE (K982358)OraSure Technologies, Inc.1998-10-02
STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) (K982061)OraSure Technologies, Inc.1998-08-25
HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS (K980739)OraSure Technologies, Inc.1998-05-26
STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) (K981341)OraSure Technologies, Inc.1998-05-22
MICRO-PLATE COTININE EIA (K974534)OraSure Technologies, Inc.1998-05-18
MICRO-PLATE COTININE EIA (K974234)OraSure Technologies, Inc.1998-05-14
STC CANNABINOIDS MICRO-PLATE EIA (K973750)OraSure Technologies, Inc.1998-02-13
STC METHAMPHETAMINE MICRO-PLATE EIA (K972989)OraSure Technologies, Inc.1998-01-28
STC COCAINE METABOLITE MICRO-PLATE EIA (K973651)OraSure Technologies, Inc.1998-01-02
AUTO-LYTE COTININE EIA (K972481)OraSure Technologies, Inc.1997-10-21
HISTOFREEZER VERRUCA PLANA (K971392)OraSure Technologies, Inc.1997-10-21
STC AUTO-LYTE URINARY GLUCOSE ASSAY (K962435)OraSure Technologies, Inc.1996-12-26

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