FDA.reportPublic FDA data

Opiate/opiate metabolite 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 opiate and/or opiate metabolites in a clinical specimen.
GUDID devices
54
Last updated
2026-07-23 06:05:08

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B800FENTHIGHWBSCFL0FENTANYL PLUS HIGHUTAK LABORATORIES, INC.FENT+ HIGH WB SCFL2026-07-14
B800FENTLOWWBSCFL0FENTANYL PLUS LOWUTAK LABORATORIES, INC.FENT+ LOW WB SCFL2026-07-14
B80003716500030FENTANYL PLUS LEVEL 1UTAK LABORATORIES, INC.FENT+ 1 U PM2022-06-16
B80003716500040FENTANYL PLUS LEVEL 2UTAK LABORATORIES, INC.FENT+ 2 U PM2022-06-16
B80003716500050BUPRENORPHINE PLUS LEVEL 1UTAK LABORATORIES, INC.BUP+ 1 U PM2022-06-21
B80003716500060BUPRENORPHINE PLUS LEVEL 2UTAK LABORATORIES, INC.BUP+ 2 U PM2022-06-21
B800210700Pain Management 100UTAK LABORATORIES, INC.210702020-02-24
B800210800Pain Management 100UTAK LABORATORIES, INC.210802020-04-15
B800910000PM Plus Low UTAK LABORATORIES, INC.910002020-04-15
B800910020PM Plus HighUTAK LABORATORIES, INC.910022020-04-15
B800918030OPIATES HYDROLYSIS QCUTAK LABORATORIES, INC.918032020-07-24
00840937114674ImmunalysisIMMUNALYSIS CORP3020-152024-04-19
B80003716500051BUPRENORPHINE PLUS LEVEL 1UTAK LABORATORIES, INC.BUP+ 1 U PM2022-06-21
B80003716500061BUPRENORPHINE PLUS LEVEL 2UTAK LABORATORIES, INC.BUP+ 2 U PM2022-06-21
B80003716500031FENTANYL PLUS LEVEL 1UTAK LABORATORIES, INC.FENT+ 1 U PM2022-06-16
B80003716500041FENTANYL PLUS LEVEL 2UTAK LABORATORIES, INC.FENT+ 2 U PM2022-06-16
B80004830000010OPIATES 500 NG/MLUTAK LABORATORIES, INC.OPIA 500 U2022-04-25
00812101030790DRI™ Fentanyl II ControlARK DIAGNOSTICS INC100288752021-05-27
00850624008452LZI Hydrocodone 100 Level 1 ControlLIN-ZHI INTERNATIONAL, INC.C688262021-04-19
00850624008469LZI Hydrocodone 100 Level 2 ControlLIN-ZHI INTERNATIONAL, INC.C688272021-04-19
00850624008476LZI Hydrocodone 300 Level 1 ControlLIN-ZHI INTERNATIONAL, INC.C688282021-04-19
00850624008483LZI Hydrocodone 300 Level 2 ControlLIN-ZHI INTERNATIONAL, INC.C688292021-04-19
00811727016928Pointe Opiates 300 Level 1 Control (Morphine 225 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-OP0054-52020-09-25
00811727016935Pointe Opiates 300 Level 2 Control (Morphine 375 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-OP0056-52020-09-25
00811727017000Pointe Opiates 2000 Level 1 Control (Morphine 1500 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-OP0674-52020-09-25
00811727017017Pointe Opiates 2000 Level 2 Control (Morphine 2500 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-OP0676-52020-09-25
B800918035OPIATES HYDROLYSIS QCUTAK LABORATORIES, INC.918032020-07-24
B800210805Pain Management 100UTAK LABORATORIES, INC.210802020-04-15
B800910005PM Plus Low UTAK LABORATORIES, INC.910002020-04-15
B800910025PM Plus HighUTAK LABORATORIES, INC.910022020-04-15
00840937103487Immunalysis CorporationIMMUNALYSIS CORPORATIONC304-10-22016-08-31
00840937103494Immunalysis CorporationIMMUNALYSIS CORPORATIONC304-10-2EX2016-08-31
00840937104774Immunalysis CorporationIMMUNALYSIS CORPORATIONPOS-225-22016-08-31
00840937104781Immunalysis CorporationIMMUNALYSIS CORPORATIONPOS-225-52016-08-31
00840937104996Immunalysis CorporationIMMUNALYSIS CORPORATIONPOS-239-22016-08-31
00840937105009Immunalysis CorporationIMMUNALYSIS CORPORATIONPOS-239-52016-08-31
00840937105870Immunalysis CorporationIMMUNALYSIS CORPORATIONCP-2252016-08-31
00840937106006Immunalysis CorporationIMMUNALYSIS CORPORATIONCP-2392016-08-31
B800210705Pain Management 100UTAK LABORATORIES, INC.210702020-02-24
15099590221997SynchronBeckman Coulter, Inc.4749912016-08-24
15099590222000SynchronBeckman Coulter, Inc.4749882016-08-24
B07600270Opiate DAU Control, Level 1 ControlLIN-ZHI INTERNATIONAL, INC.00272016-07-05
B07600280Opiate DAU Control, Level 2 ControlLIN-ZHI INTERNATIONAL, INC.00282016-07-05
B07603370Opiate 2000 DAU Control, Level 1 ControlLIN-ZHI INTERNATIONAL, INC.03372016-07-05
B07603380Opiate 2000 DAU Control, Level 2 ControlLIN-ZHI INTERNATIONAL, INC.03382016-07-05
B07603870Hydrocodone 100 DAU Control, Level 1 ControlLIN-ZHI INTERNATIONAL, INC.03872016-07-05
B07603880Hydrocodone 100 DAU Control, Level 2 ControlLIN-ZHI INTERNATIONAL, INC.03882016-07-05
B07603970Hydrocodone 300 DAU Control, Level 1 ControlLIN-ZHI INTERNATIONAL, INC.03972016-07-05
B07603980Hydrocodone 300 DAU Control, Level 2 ControlLIN-ZHI INTERNATIONAL, INC.03982016-07-05
00850624008117Hydrocodone 100 Control SetLIN-ZHI INTERNATIONAL, INC.083047421902018-04-20
00850624008131Hydrocodone 300 Control SetLIN-ZHI INTERNATIONAL, INC.082398511902018-04-20
00858724003421ARK™ Fentanyl ControlARK DIAGNOSTICS INC5031-0003-002017-04-30
00858724003698ARK™ Fentanyl Control (WPT)ARK DIAGNOSTICS INC5052-0003-002018-04-26
00884883000360DRI Hydrocodone ControlsMicrogenics Corporation100181492017-09-28