FDA.reportPublic FDA data

Fentanyl IVD, reagent

Definition
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of fentanyl in a clinical specimen.
GUDID devices
12
Last updated
2026-02-25 21:47:41

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850076346027HealgenHEALGEN LIFE SCIENCE, LLCFBFEN-102G2026-02-06
16970429843315co-innovationCo-Innovation Biotech Co., LtdFYL TEST2024-08-20
00840937100349Immunalysis CorporationIMMUNALYSIS CORPORATION218-00962016-08-31
00840937100356Immunalysis CorporationIMMUNALYSIS CORPORATION218-04802016-08-31
00840937100363Immunalysis CorporationIMMUNALYSIS CORPORATION218-48002016-08-31
00840937104675Immunalysis CorporationIMMUNALYSIS CORPORATIONPOS-218-22016-08-31
00840937104682Immunalysis CorporationIMMUNALYSIS CORPORATIONPOS-218-52016-08-31
00840937105436Immunalysis CorporationIMMUNALYSIS CORPORATIONCB-4182016-08-31
00840937105818Immunalysis CorporationIMMUNALYSIS CORPORATIONCP-2182016-08-31
00840937106594Immunalysis CorporationIMMUNALYSIS CORPORATIONFC-218-152016-08-31
00840937106600Immunalysis CorporationIMMUNALYSIS CORPORATIONFC-218-602016-08-31
00840937106617Immunalysis CorporationIMMUNALYSIS CORPORATIONFC-218-7502016-08-31