FDA.reportPublic FDA data

Oxycodone 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 oxycodone in a clinical specimen.
GUDID devices
25
Last updated
2021-08-27 11:54:55

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B07606170LZI Oxycodone 100 Level 1 ControlLIN-ZHI INTERNATIONAL, INC.06172021-08-19
B07606270LZI Oxycodone 300 Level 1 ControlLIN-ZHI INTERNATIONAL, INC.06272021-08-19
B07606280LZI Oxycodone 300 Level 2 ControlLIN-ZHI INTERNATIONAL, INC.06282021-08-19
B07606180LZI Oxycodone 100 Level 2 ControlLIN-ZHI INTERNATIONAL, INC.06182021-08-18
00811727017475Pointe Oxycodone Control (75 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-OX0484-52020-09-25
00811727017499Pointe Oxycodone Control (125 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-OX0488-52020-09-25
00811727017536Pointe Oxycodone Control (225 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-OX0490-52020-09-25
00811727017543Pointe Oxycodone Control (375 ng/mL)HORIBA INSTRUMENTS INCORPORATED60-OX0494-52020-09-25
00840937103371ImmunalysisIMMUNALYSIS CORPC302UR-10-2-1002016-08-31
00840937103388ImmunalysisIMMUNALYSIS CORPC302UR-10-2-3002016-08-31
00840937110966Immunalysis CorporationIMMUNALYSIS CORPORATION3016-52018-06-22
00840937111246ImmunalysisIMMUNALYSIS CORP04W33-112018-06-29
00840937111253ImmunalysisIMMUNALYSIS CORP04W33-122018-06-29
00840937111536ImmunalysisIMMUNALYSIS CORP04Z45-112019-02-28
00840937111543ImmunalysisIMMUNALYSIS CORP04Z45-122019-02-28
B0760242B0Oxycodone 100 DAU Control, Level 1 ControlLIN-ZHI INTERNATIONAL, INC.0242b2016-07-05
B0760244B0Oxycodone 100 DAU Control, Level 2 ControlLIN-ZHI INTERNATIONAL, INC.0244b2016-07-05
B0760245B0Oxycodone 300 DAU Control, Level 1 ControlLIN-ZHI INTERNATIONAL, INC.0245b2016-07-05
B0760247B0Oxycodone 300 DAU Control, Level 2 ControlLIN-ZHI INTERNATIONAL, INC.0247b2016-07-05
00884883005167DRI Oxycodone 100 ControlsMicrogenics Corporation1002542016-09-12
00884883005174DRI Oxycodone 300 ControlsMicrogenics Corporation1002552016-09-12
00630414027975Emit II Plus Oxycodone Positive Control 300Siemens Healthcare Diagnostics Inc.107208122018-06-09
00630414027982Emit II Plus Oxycodone Negative Control 300Siemens Healthcare Diagnostics Inc.107208112018-06-09
00630414027999Emit II Plus Oxycodone Positive Control 100Siemens Healthcare Diagnostics Inc.107208102018-06-09
00630414028002Emit II Plus Oxycodone Negative Control 100Siemens Healthcare Diagnostics Inc.107208092018-06-09