Cogent Diagnotics , Ltd.
Medical device manufacturer in Midlothian, Scotland, GB.
31510(k) clearances
0PMA approvals
0recalls
Device types
- LLL Extractable Antinuclear Antibody, Antigen… 7
- JNL Immunochemical, Thyroglobulin Autoantibody 3
- MID System, Test, Anticardiolipin Immunological 3
- DHR System, Test, Rheumatoid Factor 3
- JZO System, Test, Thyroid Autoantibody 2
- MOB Test System, Antineutrophil Cytoplasmic… 2
- MST Antibodies, Gliadin 2
- LKJ Antinuclear Antibody, Antigen, Control 1
- JJX Single (Specified) Analyte Controls… 1
- DDC Thyroglobulin, Antigen, Antiserum, Control 1
- LRM Anti-Dna Antibody (Enzyme-Labeled)… 1
- LJM Antinuclear Antibody (Enzyme-Labeled)… 1
- LKO Anti-Rnp Antibody, Antigen And Control 1
- LKP Anti-Sm Antibody, Antigen And Control 1
- MVJ Devices, Measure, Antibodies To Glomerular… 1
- MLE Enzyme Immunoassay, Antiparietal Cell… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K003057 | Autostat II ENA-4 Profile ElisaLLL · Traditional | 10/13/2000SE |
| K003054 | Autostat II ENA-6 Profile ElisaLLL · Traditional | 10/13/2000SE |
| K002215 | Autostat II Anti-Myeloperoxidase (Mpo) ElisaMOB · Traditional | 09/28/2000SE |
| K993557 | Autostat II Rheumatoid Factor Iga ElisaDHR · Traditional | 03/03/2000SE |
| K994338 | Autostat II Rheumatoid Factor Igm ElisaDHR · Traditional | 02/03/2000SE |
| K993085 | Autostat II Anti-Cardiolipin Screen ElisaMID · Traditional | 02/01/2000SE |
| K993304 | Autostat II Rheumatoid Factor Igg ElisaDHR · Traditional | 12/06/1999SE |
| K992449 | Autostat II Anti-Cardiolipin Igm ElisaMID · Traditional | 11/24/1999SE |
| K993087 | Autostat II Anti-Gliadin Igg ElisaMST · Traditional | 11/12/1999SE |
| K993086 | Autostat II Anti-Gliadin Iga ElisaMST · Traditional | 11/12/1999SE |
| K992440 | Autostat II Anti-Cardiolipin Igg ElisaMID · Traditional | 09/21/1999SE |
| K991942 | Autostat II Anti-Gpc Elisa, Hy.Tec Anti-Gpc ElisaMLE · Traditional | 08/24/1999SE |
| K991890 | Autostat II Anti-Gbm Elisa, Hy.Tec Anti-Gmb ElisaMVJ · Traditional | 08/09/1999SE |
| K990798 | Autostat II ANTI-JO-1 ElisaLLL · Traditional | 04/28/1999SE |
| K990797 | Autostat II ANTI-SCL-70 ElisaLLL · Traditional | 04/28/1999SE |
| K990796 | Autostat II Anti-Pr 3 (C-Anca)Elisa, Hy*Tec Anti-Pr 3 (C-Anca)ElisaMOB · Traditional | 04/28/1999SE |
| K990627 | Autostat II Anti-Ss-A/Ro ElisaLLL · Traditional | 04/28/1999SE |
| K990626 | Autostat II Anti-Ss-B/La ElisaLLL · Traditional | 04/28/1999SE |
| K990625 | Autostat II Anti-Sm ElisaLKP · Traditional | 04/28/1999SE |
| K990624 | Autostat II Anti-Sm/Rnp ElisaLKO · Traditional | 04/28/1999SE |
| K983655 | Autostat II Ana Screen ElisaLJM · Traditional | 01/28/1999SE |
| K983921 | Autostat II Ena Screen ElisaLLL · Traditional | 12/28/1998SE |
| K952567 | Autostattmii Anti-DsdnaLRM · Traditional | 03/04/1997SE |
| K943580 | Autostat II Anti-TpoJNL · Traditional | 04/17/1995SE |
| K943625 | Autostat II Anti-ThyroglobulinDDC · Traditional | 12/22/1994SE |
| K925783 | Autostat Anti-DsdnaJJX · Traditional | 03/22/1993SE |
| K925785 | Autostat Anti-Thyroid Microsomal KitJZO · Traditional | 01/21/1993SE |
| K925784 | Autostat AntithyroglobinJZO · Traditional | 01/21/1993SE |
| K923371 | Autostat Anti-Thyroid MicrossomalJNL · Traditional | 09/22/1992SE |
| K923370 | Autostat Anti-ThyroglobulinJNL · Traditional | 09/22/1992SE |
| K913342 | Autostat(Tm) Anti-DsnaLKJ · Traditional | 05/01/1992SE |