FDA.reportPublic FDA data

Ethanol (ETOH) IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen.
GUDID devices
23
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00896863002233Ammonia Alcohol Control Level 1 Set 3x5mLQUANTIMETRIX CORPORATION1311-312018-09-26
00896863002240Ammonia Alcohol Control Level 2 Set 3x5mLQUANTIMETRIX CORPORATION1312-312018-09-26
00896863002257Ammonia Alcohol Control Level 3 Set 3x5mLQUANTIMETRIX CORPORATION1313-312018-09-26
B800310800Ethanol 80mg/dL UTAK LABORATORIES, INC.310802020-04-15
B800ETH120UTCRFL0ETHANOL 120 MG/DLUTAK LABORATORIES, INC.ETH 120 U TCRFL2023-01-12
00811727017420Pointe Ethyl Alcohol Level 1 Control (50 mg/dL)HORIBA INSTRUMENTS INCORPORATED60-EA0448-52020-09-25
00811727017437Pointe Ethyl Alcohol Level 2 Control (300 mg/dL)HORIBA INSTRUMENTS INCORPORATED60-EA0450-52020-09-25
00847661005094LiquichekBIO-RAD LABORATORIES, INC.2732020-09-14
03610522046140InteliQBIO-RAD LABORATORIES, INC.120082992020-09-14
03610522046157InteliQBIO-RAD LABORATORIES, INC.120083002020-09-14
03610522046164InteliQBIO-RAD LABORATORIES, INC.120083012020-09-14
03610522046171InteliQBIO-RAD LABORATORIES, INC.120083022020-09-14
00810042682672Alco-ScreenBIOCHEMICAL DIAGNOSTICS INC557002020-09-02
B800310805Ethanol 80mg/dL UTAK LABORATORIES, INC.310802020-04-15
00810042681163SalivabuseBIOCHEMICAL DIAGNOSTICS INC557002020-01-28
00810042680586DetectabuseBIOCHEMICAL DIAGNOSTICS INC180075362020-02-10
05055273207873EtOH CAL/CONTROLRANDOX LABORATORIES LIMITEDDA27032016-09-24
00842768001987Syva® Emit® Ethyl Alcohol Low ControlSiemens Healthcare Diagnostics Inc.104454472016-09-24
00842768002007Syva® Emit® Ethyl Alcohol High ControlSiemens Healthcare Diagnostics Inc.104454492016-09-24
00884883001015DRI 50 mg/dL Alcohol ControlMicrogenics Corporation02392017-10-30
00884883001039DRI 300 mg/dL Alcohol ControlMicrogenics Corporation02432017-10-30
00380740005535ARCHITECTABBOTT LABORATORIES3L36-102016-06-06
00380740005542ARCHITECTABBOTT LABORATORIES3L36-122016-06-06