Ortho Diagnostic Systems, Inc.

FDA 510(k) & PMA Approved Devices — 126 products

Total Devices126

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K951459	ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE	GKZ	1997-07-14	View
510(k)	K951632	ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)	GKZ	1997-03-06	View
510(k)	K964754	ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE	GKZ	1997-01-22	View
510(k)	K963902	QUANTITATIVE FIBRINOGEN ASSAY	GIS	1996-11-29	View
510(k)	K950568	ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)	GKZ	1996-05-13	View
510(k)	K951100	ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)	GKZ	1996-05-13	View
510(k)	K950625	ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)	GKZ	1996-05-13	View
510(k)	K950482	ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)	GKZ	1996-05-10	View
510(k)	K935720	ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM	GKZ	1996-05-09	View
510(k)	K954570	ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM	GKZ	1996-04-30	View
510(k)	K955638	SYNTHAFAX APTT REAGENT	GFO	1996-04-23	View
510(k)	K953981	SYNTHASIL APTT REAGENT	GFO	1995-11-30	View
510(k)	K941192	ORTHO ALT MICROWELL TEST SYSTEM	CKD	1995-05-16	View
510(k)	K940209	ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL	GGN	1995-05-11	View
510(k)	K935748	ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT	GJS	1995-04-26	View
510(k)	K932532	ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE)	GKZ	1995-04-26	View
510(k)	K932530	ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE)	GKZ	1995-04-26	View
510(k)	K941713	ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE)	GKZ	1995-04-26	View
510(k)	K932531	ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE	GKZ	1995-04-26	View
510(k)	K931443	ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS	LSE	1993-11-05	View