FDA.reportPublic FDA data

Benzodiazepine group IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple benzodiazepines in a clinical specimen.
GUDID devices
59
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04250317543820Plasma ControlChromsystems Instruments + Chemicals GmbH00522020-07-30
04250317543837Plasma ControlChromsystems Instruments + Chemicals GmbH00532020-07-30
04250317545268Plasma ControlChromsystems Instruments + Chemicals GmbH02382020-07-30
04250317545275Plasma ControlChromsystems Instruments + Chemicals GmbH02392020-07-30
04250317545282Plasma ControlChromsystems Instruments + Chemicals GmbH02412020-07-30
04250317545299Plasma ControlChromsystems Instruments + Chemicals GmbH02422020-07-30
B800003575000307-AMINO PLUS 100 NG/MLUTAK LABORATORIES, INC.7-AMINO+ 100 MP2022-08-11
B80003716500090BENZODIAZEPINES +25%UTAK LABORATORIES, INC.BENZO +25 PM2022-08-15
B80003716500100BENZODIAZEPINES -25%UTAK LABORATORIES, INC.BENZO -25 PM2022-08-15
B800120900Benzodiazepines Plus 100ng/mLUTAK LABORATORIES, INC.120902020-04-15
B800120910Benzodiazepines Plus 400ng/mLUTAK LABORATORIES, INC.120912020-04-15
B800121000Benzodiazepines Plus 100ngUTAK LABORATORIES, INC.121002020-04-15
B800918000BENZODIAZEPINES HYDROLYSIS QCUTAK LABORATORIES, INC.918002020-07-24
B800BENZO25PM0BENZODIAZEPINES +25%UTAK LABORATORIES, INC.BENZO +25 PM2023-04-17
B800DS1SID0SERUM DRUG SCREEN LEVEL 1UTAK LABORATORIES, INC.DS 1 S ID2023-01-10
B800DS2SID0SERUM DRUG SCREEN LEVEL 2UTAK LABORATORIES, INC.DS 2 S ID2023-01-10
B800DS3SID0SERUM DRUG SCREEN LEVEL 3UTAK LABORATORIES, INC.DS 3 S ID2023-01-10
B800DS4SID0SERUM DRUG SCREEN LEVEL 4UTAK LABORATORIES, INC.DS 4 S ID2023-01-10
B800DS5SID0SERUM DRUG SCREEN LEVEL 5UTAK LABORATORIES, INC.DS 5 S ID2023-01-10
B800BENZO25PM5BENZODIAZEPINES +25%UTAK LABORATORIES, INC.BENZO +25 PM2023-04-17
B80003716500091BENZODIAZEPINES +25%UTAK LABORATORIES, INC.BENZO +25 PM2022-08-15
B80003716500101BENZODIAZEPINES -25%UTAK LABORATORIES, INC.BENZO -25 PM2022-08-15
B800003575000317-AMINO PLUS 100 NG/MLUTAK LABORATORIES, INC.7-AMINO+ 100 MP2022-08-11
00812101030547ARK™ HS Benzodiazepine II 75/125ng/mL ControlARK DIAGNOSTICS INC5073-0003-002021-08-31
00812101030554ARK™ HS Benzodiazepine II 150/250ng/mL ControlARK DIAGNOSTICS INC5073-0003-012021-08-31
00811727017161Pointe Benzodiazepine Control (Oxazepam 400 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-BZ0272-52020-09-25
04250317511430Plasma Control Bi-Level Chromsystems Instruments + Chemicals GmbH00512020-07-30
04250317511676Plasma ControlChromsystems Instruments + Chemicals GmbH00522020-07-30
04250317511706Plasma ControlChromsystems Instruments + Chemicals GmbH00532020-07-30
04250317512758Plasma Control Bi-Level Chromsystems Instruments + Chemicals GmbH00572020-07-30
04250317513564Plasma Control Bi-Level Chromsystems Instruments + Chemicals GmbH00612020-07-30
04250317513649Plasma Control Bi-Level Chromsystems Instruments + Chemicals GmbH00622020-07-30
04250317524140Plasma ControlChromsystems Instruments + Chemicals GmbH02382020-07-30
04250317524157Plasma ControlChromsystems Instruments + Chemicals GmbH02392020-07-30
04250317524164Plasma Control Bi-Level Chromsystems Instruments + Chemicals GmbH02372020-07-30
04250317524201Plasma ControlChromsystems Instruments + Chemicals GmbH02412020-07-30
04250317524225Plasma ControlChromsystems Instruments + Chemicals GmbH02422020-07-30
04250317524232Plasma Control Bi-Level Chromsystems Instruments + Chemicals GmbH02402020-07-30
B800918005BENZODIAZEPINES HYDROLYSIS QCUTAK LABORATORIES, INC.918002020-07-24
B800120905Benzodiazepines Plus 100ng/mLUTAK LABORATORIES, INC.120902020-04-15
B800120915Benzodiazepines Plus 400ng/mLUTAK LABORATORIES, INC.120912020-04-15
B800121005Benzodiazepines Plus 100ngUTAK LABORATORIES, INC.121002020-04-15
00840937104644Immunalysis CorporationIMMUNALYSIS CORPORATIONPOS-216-22016-08-31
00840937104873Immunalysis CorporationIMMUNALYSIS CORPORATIONPOS-233-22016-08-31
00840937104880Immunalysis CorporationIMMUNALYSIS CORPORATIONPOS-233-52016-08-31
00840937105948Immunalysis CorporationIMMUNALYSIS CORPORATIONCP-2332016-08-31
00840937110201Immunalysis CorporationIMMUNALYSIS CORPORATION3013-52017-05-31
00840937110218Immunalysis CorporationIMMUNALYSIS CORPORATION3013-5EX2017-05-31
00840937110225Immunalysis CorporationIMMUNALYSIS CORPORATION3013-152017-05-31
00840937110232Immunalysis CorporationIMMUNALYSIS CORPORATION3013-15EX2017-05-31
B07601320Benzodiazepine DAU Calibrator/Control, Calibrator #2/Control 1LIN-ZHI INTERNATIONAL, INC.01322016-07-05
B07601330Benzodiazepine DAU Calibrator/Control, Calibrator #3/Cutoff A/Control 2LIN-ZHI INTERNATIONAL, INC.01332016-07-05
B07601340Benzodiazepine DAU Calibrator/Control, Calibrator #4/Cutoff B/Control 3LIN-ZHI INTERNATIONAL, INC.01342016-07-05
B07601360Benzodiazepine DAU Control , Control 4LIN-ZHI INTERNATIONAL, INC.01362016-07-05
05055273207989BENZ CONTROL 1RANDOX LABORATORIES LIMITEDDA31302016-09-24
05055273207996BENZ CONTROL 2RANDOX LABORATORIES LIMITEDDA31312016-09-24
00847661000587LyphochekBIO-RAD LABORATORIES, INC.6622017-01-09
00847661000594LyphochekBIO-RAD LABORATORIES, INC.6632017-01-09
00847661000600LyphochekBIO-RAD LABORATORIES, INC.6642017-01-09