FDA.reportPublic FDA data

Fentanyl 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 fentanyl in a clinical specimen.
GUDID devices
15
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850624008667LZI Fentanyl Level 1 ControlLIN-ZHI INTERNATIONAL, INC.D267852025-10-13
00850624008674LZI Fentanyl Level 2 ControlLIN-ZHI INTERNATIONAL, INC.D267862025-10-13
00850624008636Fentanyl Control SetLIN-ZHI INTERNATIONAL, INC.104266671902025-06-06
00850624008407LZI Norfentanyl Level 1 ControlLIN-ZHI INTERNATIONAL, INC.C688212021-04-19
00850624008414LZI Norfentanyl Level 2 ControlLIN-ZHI INTERNATIONAL, INC.C688222021-04-19
00811727016430Pointe Norfentanyl Level 1 Control (3.75 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-NF0634-52020-09-25
00811727016447Pointe Norfentanyl Level 2 Control (6.25 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-NF0636-52020-09-25
00840937103630Immunalysis CorporationIMMUNALYSIS CORPORATIONC318-10-1-52016-08-31
00840937103661Immunalysis CorporationIMMUNALYSIS CORPORATIONC318-10-22016-08-31
00840937103678Immunalysis CorporationIMMUNALYSIS CORPORATIONC318-10-2EX2016-08-31
00840937111239ImmunalysisIMMUNALYSIS CORP04W32-102018-06-29
00840937111475ImmunalysisIMMUNALYSIS CORP04Z44-102019-02-28
00840937108772ImmunalysisIMMUNALYSIS CORP3009-52019-09-16
B07603170Norfentanyl DAU Control, Level 1 ControlLIN-ZHI INTERNATIONAL, INC.03172019-03-26
B07603180Norfentanyl DAU Control, Level 2 ControlLIN-ZHI INTERNATIONAL, INC.03182019-03-26