FDA.reportPublic FDA data

Homocysteine 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 quantitative measurement of homocysteine in a clinical specimen.
GUDID devices
20
Last updated
2019-04-03 00:02:51

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04560189212817ST AIA-PACK Homocysteine Pretreatment SetTOSOH CORPORATIONN/A2016-09-24
05055273208894HCYRANDOX LABORATORIES LIMITEDHY40362016-09-24
05055845400015Axis® Homocysteine EIAAXIS-SHIELD DIAGNOSTICS LIMITEDFHCY1002016-06-13
050558454000843-Reagent Homocysteine Assay for SYNCHRON UniCelAXIS-SHIELD DIAGNOSTICS LIMITEDFHYB100/B081752016-07-01
05055845400169Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent KitAXIS-SHIELD DIAGNOSTICS LIMITEDFHRWR1002016-07-01
05055845400176Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent KitAXIS-SHIELD DIAGNOSTICS LIMITEDFHRWR2002016-07-01
05055845400183Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent KitAXIS-SHIELD DIAGNOSTICS LIMITEDFHRWR10002016-07-01
05055845400282Axis-Shield Liquid Stable (LS) 2-Part Homocysteine ReagentAXIS-SHIELD DIAGNOSTICS LIMITEDFHBC100/B081762016-07-01
00842768006128DImension Vista® Homocysteine Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbH104458972016-09-24
00842768006715N Latex HCYSiemens Healthcare Diagnostics Products GmbH104459732016-09-24
00817089020252DiazymeDIAZYME LABORATORIES, INC.DZ568A-K2016-11-03
00817089020269DiazymeDIAZYME LABORATORIES, INC.DZ568B-K2016-11-03
00817089020870DiazymeDIAZYME LABORATORIES, INC.DZ568A-K032016-11-03
00817089020887DiazymeDIAZYME LABORATORIES, INC.DZ568A-K042016-11-03
00817089020894DiazymeDIAZYME LABORATORIES, INC.DZ568A-K052016-11-03
00817089020948DiazymeDIAZYME LABORATORIES, INC.DZ568B-BY12016-11-03
00817089020955DiazymeDIAZYME LABORATORIES, INC.DZ568B-BY22016-11-03
00817089020962DiazymeDIAZYME LABORATORIES, INC.DZ568B-SMA2016-11-03
00817089021297DiazymeDIAZYME LABORATORIES, INC.DZ568A-K072016-11-03
00817089021457DiazymeDIAZYME LABORATORIES, INC.DZ568A-KD22016-11-03