FDA.reportPublic FDA data

Buprenorphine IVD, kit, enzyme immunoassay (EIA)

Definition
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of buprenorphine in a clinical specimen, using an enzyme immunoassay (EIA) method.
GUDID devices
46
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00857275007520PreChekIDUN SOLUTIONS LLC215120500103082018-08-02
06970429841611co-innovationCo-Innovation Biotech Co., Ltd16P CUP2021-03-29
00850624008513Buprenorphine Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.090677521902021-09-15
16970429841618co-innovationCo-Innovation Biotech Co., Ltd16P CUP2021-03-29
00811727016300Pointe Buprenorphine Reagent SetHORIBA INSTRUMENTS INCORPORATED60-BP0540-1002020-09-25
00811727016317Pointe Buprenorphine Reagent SetHORIBA INSTRUMENTS INCORPORATED60-BP0540-1L2020-09-25
00840937100813Immunalysis CorporationIMMUNALYSIS CORPORATION236-00962016-08-31
00840937100820Immunalysis CorporationIMMUNALYSIS CORPORATION236-04802016-08-31
00840937100837Immunalysis CorporationIMMUNALYSIS CORPORATION236-48002016-08-31
00840937102664Immunalysis CorporationIMMUNALYSIS CORPORATION336OF-00252016-08-31
00840937102671Immunalysis CorporationIMMUNALYSIS CORPORATION336OF-01002016-08-31
00840937102688Immunalysis CorporationIMMUNALYSIS CORPORATION336OF-05002016-08-31
00840937102695ImmunalysisIMMUNALYSIS CORP336UR-00252016-08-31
00840937102701ImmunalysisIMMUNALYSIS CORP336UR-0060W2016-08-31
00840937102718ImmunalysisIMMUNALYSIS CORP336UR-01002016-08-31
00840937102725ImmunalysisIMMUNALYSIS CORP336UR-05002016-08-31
00840937105290ImmunalysisIMMUNALYSIS CORPASR-A-336-1002016-08-31
00840937105306ImmunalysisIMMUNALYSIS CORPASR-A-336-10002016-08-31
00840937106181ImmunalysisIMMUNALYSIS CORPASR-E-336-1002016-08-31
00840937106198ImmunalysisIMMUNALYSIS CORPASR-E-336-10002016-08-31
00840937109779Immunalysis CorporationIMMUNALYSIS CORPORATION336OF-0060W2017-01-13
00840937109984Immunalysis CorporationIMMUNALYSIS CORPORATION236-0096EX2017-05-15
00840937109991Immunalysis CorporationIMMUNALYSIS CORPORATION236-0480EX2017-05-15
00840937110003Immunalysis CorporationIMMUNALYSIS CORPORATION236-4800EX2017-05-15
00840937110980ImmunalysisIMMUNALYSIS CORP04W30-202018-06-29
00840937111383ImmunalysisIMMUNALYSIS CORP04Z42-202019-02-28
B07602700Buprenorphine Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.02702016-07-05
B07602710Buprenorphine Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.02712016-07-05
00850624008018Buprenorphine Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.083629551902018-04-20
00857275007285PreChek Multi-Drug Test Square CupIDUN SOLUTIONS LLCIDOA-7325SC-25P2018-06-20
00857275007421PreChekIDUN SOLUTIONS LLC215120500103082018-08-02
00869335000204Buprenorphine Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.A536842016-07-05
00884883001602CEDIA Buprenorphine AssayMicrogenics Corporation1001902016-09-12
00884883001695CEDIA Buprenorphine AssayMicrogenics Corporation1002402016-09-12
00884883003873CEDIA Bupernorphine II AssayMicrogenics Corporation100208492017-05-12
00884883004757CEDIA Bupernorphine II AssayMicrogenics Corporation100208502017-05-12
00884883011670CEDIA Buprenorphine AssayMicrogenics Corporation100156582016-09-12
00817302020823CAROLINA LIQUID CHEMISTRIES CORP.® BUP RGT. KIT ST424CAROLINA LIQUID CHEMISTRIES CORPORATIONST4242016-09-01
00817302020830CAROLINA LIQUID CHEMISTRIES CORP.® BUP RGT. KIT ST324CAROLINA LIQUID CHEMISTRIES CORPORATIONST3242016-09-01
00817302020847CAROLINA LIQUID CHEMISTRIES CORP.® BUP RGT. KIT AU-424CAROLINA LIQUID CHEMISTRIES CORPORATIONAU-4242016-09-01
00817302020854CAROLINA LIQUID CHEMISTRIES CORP.® BUP RGT. KIT BL-424CAROLINA LIQUID CHEMISTRIES CORPORATIONBL4242016-09-01
00817302020861CAROLINA LIQUID CHEMISTRIES CORP.® BUP REAGENT KIT Product No. DT424CAROLINA LIQUID CHEMISTRIES CORPORATIONDT4242016-09-01
00817302021202CAROLINA LIQUID CHEMISTRIES CORP.® BUP RGT. KIT MR424CAROLINA LIQUID CHEMISTRIES CORPORATIONMR4242016-09-01
00630414601106Syva® Emit® II Plus Buprenorphine AssaySiemens Healthcare Diagnostics Inc.107200462016-09-24
00630414601113Syva® Emit® II Plus Buprenorphine AssaySiemens Healthcare Diagnostics Inc.107200472016-09-24
00630414601120Syva® Emit® II Plus Buprenorphine AssaySiemens Healthcare Diagnostics Inc.107200482016-09-24