FDA.reportPublic FDA data

Oxycodone IVD, kit, immunochromatographic test (ICT), rapid

Definition
A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of oxycodone in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.
GUDID devices
26
Last updated
2021-05-24 17:44:57

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
90857275007813N/MIDUN SOLUTIONS LLC125111050000342019-08-26
00840937100462Immunalysis CorporationIMMUNALYSIS CORPORATION221B-00962016-08-31
00840937100479Immunalysis CorporationIMMUNALYSIS CORPORATION221B-04802016-08-31
00840937100486Immunalysis CorporationIMMUNALYSIS CORPORATION221B-48002016-08-31
B29830111C10DrugCheckExpress Diagnostic Int'l, Inc.30111C2019-04-23
B2983011110DrugCheckExpress Diagnostic Int'l, Inc.301112019-04-08
B298301110DrugCheckEXPRESS DIAGNOSTICS INT'L, INC.301112016-08-31
B29830111C0DrugCheckEXPRESS DIAGNOSTICS INT'L, INC.30111C2016-08-29
00841824101791N/AW.H.P.M. INC.WOX-Strip2016-08-01
00841824102156NAW.H.P.M. INC.WOX-252016-08-01
00817763021773FIRST SIGN®HEMOSURE INC.FSCDIPOX-252017-02-16
00817830020241RAPID DIAGNOSTICS OXYCODONE TEST STRIP KIT (50)RAPID DIAGNOSTICS INC07RD81002016-10-20
00816036020086STATDIP®MICRO DISTRIBUTING, L.CDOX-1142016-08-01
00816555020123Monitect Drug Screen Cassette TestBRANAN MEDICAL CORPORATIONMC232016-08-01
00816555021076Fastect II Drug Screen Dipstick TestBRANAN MEDICAL CORPORATIONMF232016-08-01
00816565020984Fastect II Drug Screen Dipstick TestAMEDITECH INC.MF232017-03-31
00816610020259CLIAwaivedCliawaived, Inc.CLIA-SDDT-232016-09-01
00817302021592CAROLINA LIQUID CHEMISTRIES CORP.® OXYC RGT. KIT MR419BCAROLINA LIQUID CHEMISTRIES CORPORATIONMR419B2016-09-01
00817302021608CAROLINA LIQUID CHEMISTRIES CORP.® OXYCODONE CC419BCAROLINA LIQUID CHEMISTRIES CORPORATIONCC419B2016-09-01
00817302021882CAROLINA LIQUID CHEMISTRIES CORP.® OXYC RGT. KIT ST419BCAROLINA LIQUID CHEMISTRIES CORPORATIONST419B2016-09-01
00817302021899CAROLINA LIQUID CHEMISTRIES CORP.® OXYC RGT. KIT ST319BCAROLINA LIQUID CHEMISTRIES CORPORATIONST319B2016-09-01
00817302021905CAROLINA LIQUID CHEMISTRIES CORP.® OXYC RGT. KIT AU-419BCAROLINA LIQUID CHEMISTRIES CORPORATIONAU-419B2016-09-01
00817302021912CAROLINA LIQUID CHEMISTRIES CORP.® OXYC RGT. KIT BL-419BCAROLINA LIQUID CHEMISTRIES CORPORATIONBL419B2016-09-01
00817302021929CAROLINA LIQUID CHEMISTRIES CORP.® OXYC REAGENT KIT Product No. DT419CAROLINA LIQUID CHEMISTRIES CORPORATIONDT4192016-09-01
00817405020218Alere iScreen DxInstant Technologies, Inc.IS1 OXY-DX2016-09-19
10690286000329MEDTOX® OXYCODONEMEDTOX DIAGNOSTICS, INC.6016752016-09-16