FDA.reportPublic FDA data

Amphetamine-specific 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 a specific amphetamine in a clinical specimen.
GUDID devices
11
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04015630997589Amphetamines IIRoche Diagnostics GmbH45129361902016-09-20
04015630997602Amphetamines IIRoche Diagnostics GmbH45129441902016-09-20
04015630997626Amphetamines IIRoche Diagnostics GmbH45128801902016-09-20
04015630999194Amphetamines IIRoche Diagnostics GmbH49394251902016-09-20
00840937105726Immunalysis CorporationIMMUNALYSIS CORPORATIONCP-2092016-08-31
00840937106389Immunalysis CorporationIMMUNALYSIS CORPORATIONFC-209-252016-08-31
00840937106396Immunalysis CorporationIMMUNALYSIS CORPORATIONFC-209-602016-08-31
00840937106402Immunalysis CorporationIMMUNALYSIS CORPORATIONFC-209-7502016-08-31
00840937110119Immunalysis CorporationIMMUNALYSIS CORPORATION218-0096EX2017-05-15
00840937110126Immunalysis CorporationIMMUNALYSIS CORPORATION218-0480EX2017-05-15
00840937110133Immunalysis CorporationIMMUNALYSIS CORPORATION218-4800EX2017-05-15