Ortho Diagnostic Systems, Inc.
Medical device manufacturer in Raritan, NJ.
126510(k) clearances
0PMA approvals
0recalls
Device types
- GKZ Counter, Differential Cell 16
- JJY Multi-Analyte Controls, All Kinds (Assayed) 13
- JPA System, Multipurpose For In Vitro… 5
- GJT Plasma, Coagulation Factor Deficient 5
- LFX Enzyme Linked Immunoabsorbent Assay, Rubella 5
- GGP Test, Qualitative And Quantitative Factor… 4
- LJC Enzyme Linked Immunoabsorbent Assay… 4
- LGC Enzyme Linked Immunoabsorbent Assay, Herpes… 3
- GJS Test, Time, Prothrombin 3
- DAK Complement C1q, Antigen, Antiserum, Control 3
- MCD Antigen, Ebv, Capsid 3
- GQL Antisera, Fluorescent, Herpesvirus Hominis… 3
- LIQ Enzyme Linked Immunoabsorbent Assay… 2
- DIF Drug Mixture Control Materials 2
- LGD Enzyme Linked Immunoabsorbent Assay… 2
- JJQ Colorimeter, Photometer, Spectrophotometer… 2
- LJN Antibody Igm, If, Epstein-Barr Virus 2
- HHT Spatula, Cervical, Cytological 2
- LJP Antiserum, Fluorescent, Chlamydia Trachomatis 2
- LIP Enzyme Linked Immunoabsorption Assay… 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K951459 | Ortho-Mune Okt 4A (CD4) - Monoclonal Antibody (Murine) Fitc ConjugateGKZ · Traditional | 07/14/1997SE |
| K951632 | Ortho-Mune Ok-Combo Control IGG2A-FITC/IGG2A-PE Monoclonal Antibody (Murine)GKZ · Traditional | 03/06/1997SE |
| K964754 | Ortho-Mune Okb (CD19)- Monoclonal Antibody (Murine) Phycoerythrine ConjugateGKZ · Traditional | 01/22/1997SE |
| K963902 | Quantitative Fibrinogen AssayGIS · Traditional | 11/29/1996SE |
| K951100 | Ortho-Mune Ok-Combo CD3-FITC/CD19-PE (OKT3/OKB19A Monolclonal Antibody (Murine)GKZ · Traditional | 05/13/1996SE |
| K950625 | Ortho-Mune Ok-Combo CD40FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine)GKZ · Traditional | 05/13/1996SE |
| K950568 | Ortho-Mune Ok-Combo CD3-FITC/CD4-PE (OKT2/OKT4A) Monoclonal Antibody (Murine)GKZ · Traditional | 05/13/1996SE |
| K950482 | Ortho-Mune Ok-Comvo CD3-FITC/CD8-PE (Okt 3/OKT8) Monoclonal Antibody (Murine)GKZ · Traditional | 05/10/1996SE |
| K935720 | Ortho Count Calibration Kit for Ortho Cytoronabsolute Laser Flow Cytometry SystemGKZ · Traditional | 05/09/1996SE |
| K954570 | Ortho Immunocount Flow Cytometry SystemGKZ · Traditional | 04/30/1996SE |
| K955638 | Synthafax Aptt ReagentGFO · Traditional | 04/23/1996SE |
| K953981 | Synthasil Aptt ReagentGFO · Traditional | 11/30/1995SE |
| K941192 | Ortho Alt Microwell Test SystemCKD · Traditional | 05/16/1995SE |
| K940209 | Ortho Assayed Reference Plasma-Normal/ Plasma-AbnormalGGN · Traditional | 05/11/1995SE |
| K941713 | Ortho-Mune 0KT 11 (CD2) Monoclonal Antibody (Murine)GKZ · Traditional | 04/26/1995SE |
| K935748 | Ortho Recombiplastin II W/Ortho Recombiplastin II DiluentGJS · Traditional | 04/26/1995SE |
| K932532 | Ortho-Mune OKT8 (CD8) Monoclonal Antibody (Murine)GKZ · Traditional | 04/26/1995SE |
| K932531 | Ortho-Mune Okt 4 (CD4) Monoclonal Antibody MurineGKZ · Traditional | 04/26/1995SE |
| K932530 | Ortho-Mune Okt 3 Monoclonal Antibody (Murine)GKZ · Traditional | 04/26/1995SE |
| K931443 | Ortho*Epstein-Barr Virus Ea(D+R)-Igg Antibody ElisLSE · Traditional | 11/05/1993SE |
| K930020 | Ortho*Epstein-Barr Virus Vca-Igm Antibody ElisaLJN · Traditional | 07/16/1993SE |
| K930002 | Ortho*Epstein-Barr Virus Ebna-Iff Antibody ElisaLLM · Traditional | 07/16/1993SE |
| K925604 | Ortho(Tm) Recombiplastin W/Ortho DiluentGJS · Traditional | 03/12/1993SE |
| K925208 | Ortho HSV Antigen Elisa Test, ModificationLGC · Traditional | 12/28/1992SE |
| K914188 | Koagulab CTS Chromogrnic Testing SystemJPA · Traditional | 08/26/1992SE |
| K921321 | Ortho Chlamydia Antigen Elisa TestLJC · Traditional | 08/11/1992SE |
| K920412 | Modified Ortho Ebv Vca-Igg ElisaMCD · Traditional | 06/22/1992SE |
| K915551 | Ortho HSV Antigen Elisa TestLGC · Traditional | 04/22/1992SE |
| K911571 | Epstein-Barr Virus Vca-Igg Antibody Elisa TestMCD · Traditional | 06/10/1991SE |
| K911570 | Epstein-Barr Virus Vca-Igm Antibody Elisa TestMCD · Traditional | 06/10/1991SE |
| K911569 | Epstein-Barr Virus Ebna-Igg Antibody Elisa TestLLM · Traditional | 06/10/1991SE |
| K904253 | Ortho Mune OKT3,4, and 8 Monoclonal AntibodyGKZ · Traditional | 05/20/1991SE |
| K910668 | Ortho* Chlamydia Antigen Elisa Test/ModificationLJC · Traditional | 03/19/1991SE |
| K903132 | Ortho Chlamydia Antigen Elisa/Elisa Cult Extra BufLJC · Traditional | 12/21/1990SE |
| K905078 | Ortho Cmv-G Antibody Elisa TestLFZ · Traditional | 12/17/1990SE |
| K905077 | Ortho Cmv-M Antibody Elisa TestLFZ · Traditional | 12/17/1990SE |
| K905079 | Ortho Rubella-M Antibody Elisa TestLFX · Traditional | 12/04/1990SE |
| K902210 | Orthokrome Normal and Abnormal Control PlasmaGGN · Traditional | 07/03/1990SE |
| K901327 | Ortho Correction ReagentsGJT · Traditional | 05/25/1990SE |
| K901120 | Koagulab 60-S Coagulation SystemGKP · Traditional | 05/22/1990SE |
| K901233 | Ortho Abnormal Protein C Control PlasmaGGC · Traditional | 04/11/1990SE |
| K900400 | Orthokrome* AntithrombinJBQ · Traditional | 03/15/1990SE |
| K900399 | Orthokrome* PlasminogenGGP · Traditional | 03/15/1990SE |
| K900398 | Orthokrome* Protein CGGP · Traditional | 03/15/1990SE |
| K900397 | Orthokrome* AntiplasminGGP · Traditional | 03/15/1990SE |
| K900396 | Orthokrome* HeparinKFF · Traditional | 03/15/1990SE |
| K900395 | Orthokrome* Factor ViiiGGP · Traditional | 03/15/1990SE |
| K896479 | Ortho* Rubella-G Antibody Elisa TestLFX · Traditional | 12/29/1989SE |
| K894420 | Ortho Result Plus/PregnancyJHI · Traditional | 10/04/1989SE |
| K891382 | Ortho HSV 1&2 Dichromatic Typing Reagent & SlidesGQL · Traditional | 06/06/1989SE |
| K883937 | Ortho* Toxoplasma-G Antibody Elisa TestLGD · Traditional | 02/07/1989SE |
| K885035 | Koagulab* 32-S Coagulation SystemGKP · Traditional | 02/03/1989SE |
| K884617 | Ortho Result Plus/Rubella Rapid Color. ImmunoassayLFX · Traditional | 02/02/1989SE |
| K883940 | Ortho* Rotavirus Latex Agglutination TestLIQ · Traditional | 01/04/1989SE |
| K883935 | Ortho* Rotavirus Antigen Elisa TestLIQ · Traditional | 01/04/1989SE |
| K883939 | Ortho* Syphilis-G Antibody Elisa TestLIP · Traditional | 12/22/1988SE |
| K883938 | Ortho* Syphilis-M Antibody Elisa TestLIP · Traditional | 12/22/1988SE |
| K883692 | Ortho Factor Vii Deficient PlasmaGJT · Traditional | 11/01/1988SE |
| K883691 | Ortho Factor Xi Deficient PlasmaGJT · Traditional | 11/01/1988SE |
| K883690 | Ortho Factor X Deficient PlasmaGJT · Traditional | 11/01/1988SE |
| K883689 | Ortho Owren's BufferJPA · Traditional | 11/01/1988SE |
| K883688 | Ortho Factor Xii Deficient PlasmaGJT · Traditional | 11/01/1988SE |
| K883936 | Ortho* Toxoplasma-M Antibody Elisa TestLGD · Traditional | 10/06/1988SE |
| K881932 | Ortho* Cytomegalovirus Identification ReagentGQH · Traditional | 08/01/1988SE |
| K872541 | Ortho Monolert* Rapid Elisa Test for Infect. Mono.LJN · Traditional | 05/13/1988SE |
| K881500 | Ortho* Chlamydia Direct Detection (Fa) TestLJP · Traditional | 04/27/1988SE |
| K875162 | Ortho* Specimen Collection Cytology BrushHHT · Traditional | 01/27/1988SE |
| K872628 | Gonospot* DNA Probe Culture Confirmation TestLSL · Traditional | 12/21/1987SE |
| K872730 | Result Plus/Hcg Pregnancy TestJHI · Traditional | 10/20/1987SE |
| K871552 | Ortho* Specimen Collection CytobrushHHT · Traditional | 06/26/1987SE |
| K863490 | Ortho* Chlamydia Antigen Elisa Test & TransportLJC · Traditional | 11/05/1986SE |
| K862537 | Koagulab* M Coagulation SystemJPA · Traditional | 07/21/1986SE |
| K854488 | Ortho HSV Antigen Elisa TestGQN · Traditional | 02/04/1986SE |
| K853738 | Ortho Chlamydia Direct Detection (Fa) TestLJP · Traditional | 12/06/1985SE |
| K853328 | Koagulab 16-S Semi-Automated Coagulation SysJPA · Traditional | 11/05/1985SE |
| K852360 | Ortho DNA Probe HSV Confirmation TestGQL · Traditional | 09/12/1985SE |
| K853500 | Ortho Viral TransportJSM · Traditional | 08/28/1985SE |
| K852834 | Ortho Hematology Cont 14 Normal, 14 Abnormal H & L · Traditional | 08/08/1985SE |
| K851641 | Thrombosil Silica Activated PTT Reagent ThromboxilMSJ · Traditional | 07/23/1985SE |
| K842216 | Cultureset HSV Isolation & Id SysGQL · Traditional | 01/29/1985SE |
| K843535 | Ortho Brain Thromboplastin DiluentGJS · Traditional | 12/12/1984SE |
| K842047 | Ortho* RSV Antigen Elisa Test SysLKT · Traditional | 10/05/1984SE |
| K841527 | Ortho Respiratory Syncytial Virus-LKT · Traditional | 08/12/1984SE |
| K841526 | Ortho Varicella-Zoster Virus Ident.GQX · Traditional | 06/25/1984SE |
| K833636 | Ortho* Serum Elisa Test SystemDAK · Traditional | 06/13/1984SE |
| K841557 | Ortho Microwell ReaderJJQ · Traditional | 05/22/1984SE |
| K841200 | Rubella Igg Antibody Elisa Test SysLFX · Traditional | 05/21/1984SE |
| K834449 | HSV Antigen Elisa KitLGC · Traditional | 05/02/1984SE |
| K834064 | Ortho Bi-Level Receptor ControlJJY · Traditional | 03/23/1984SE |
| K833834 | Ortho Bacteriuria Detection SysJXA · Traditional | 03/12/1984SE |
| K833137 | Ortho B-Hcg Slide Test for PregnancyJHJ · Traditional | 01/18/1984SE |
| K833618 | Ortho ELT-8/DS Hematology AnalyzerGKZ · Traditional | 01/13/1984SE |
| K832947 | Ortho Cell CULTURES-MRC-5 Human EmbryoKIR · Traditional | 09/29/1983SE |
| K831670 | Ortho*Pap-Ia Endogenous Enzyme ImmunoJFH · Traditional | 08/24/1983SE |
| K832225 | Ortho Abnormal Coagulation Level I/IiJPA · Traditional | 08/12/1983SE |
| K831271 | ELT-8/DS Hematology Analyzer & LysrigGKZ · Traditional | 07/26/1983SE |
| K831500 | Tri-Level TDM Control & I II IIIDIF · Traditional | 06/30/1983SE |
| K822342 | Ortho Rubella Elisa Test SystemLFX · Traditional | 03/17/1983SE |
| K823590 | Manualisa Microtitration Plate ReaderJJQ · Traditional | 02/28/1983SE |
| K823490 | Ortho Bi-Level Assayed Lipid ProfileJJY · Traditional | 01/05/1983SE |
| K823131 | Koagulab 40-A Automated Coagulation SysKQG · Traditional | 12/09/1982SE |
| K822782 | AcuscreenGGW · Traditional | 10/08/1982SE |
| K821975 | Ortho*-Bi-Level Assayed Whole Blood ToxDIF · Traditional | 08/27/1982SE |
| K821949 | Ortho* Alternative Pathway Compl. TestDAK · Traditional | 08/27/1982SE |
| K821026 | Bi-Level Assayed Tumor Marker & AntinJJY · Traditional | 08/10/1982SE |
| K821898 | Ortho Classical Pathway Compl. TestDBA · Traditional | 07/16/1982SE |
| K820643 | Ortho Spectrum III & Ortho-Mune OkLIZ · Traditional | 07/14/1982SE |
| K821806 | Ortho CLG Immune Complex Test SystemDAK · Traditional | 06/25/1982SE |
| K820199 | Fetalscreen · Traditional | 05/12/1982SE |
| K820400 | Ortho* Hematology Control 8 NormalJPK · Traditional | 03/15/1982SE |
| K820392 | Ortho* Bi-Level Assayed Alcohol DiluenLAS · Traditional | 03/04/1982SE |
| K820255 | Bi-Level Assayed Urine Metal ControlJJY · Traditional | 02/18/1982SE |
| K813322 | Ortho* Unassayed Control Serum Level IIIJJY · Traditional | 12/17/1981SE |
| K813321 | Ortho* Unassayed Control Serum Level IJJY · Traditional | 12/17/1981SE |
| K813295 | Ortho CO2 Diluent Level IIIJJY · Traditional | 12/17/1981SE |
| K813294 | Ortho CO2 Diluent Level IIJJY · Traditional | 12/17/1981SE |
| K813293 | Ortho CO2 Diluent Level IJJY · Traditional | 12/17/1981SE |
| K813167 | Ortho Unassayed Control Serum Level IIJJY · Traditional | 11/24/1981SE |
| K812002 | EluaidGGK · Traditional | 10/28/1981SE |
| K811713 | Avi-D ControlKSF · Traditional | 10/23/1981SE |
| K811567 | Ortho* Bi-Level Assayed Glycoh. Contr. SLCP · Traditional | 09/16/1981SE |
| K811894 | Ortho Sickle Cell ControlsGKA · Traditional | 07/27/1981SE |
| K811467 | Doxepin/Desmethldoxepin/LithiumJJY · Traditional | 06/12/1981SE |
| K811466 | Amitriptyline/Nortriptyline/LithiumJJY · Traditional | 06/12/1981SE |
| K811465 | Imipramine/Disipramine/LithiumJJY · Traditional | 06/12/1981SE |
| K810058 | Ortho Quantitative Fibrinogen AssayKQJ · Traditional | 02/26/1981SE |