MOB — Test System, Antineutrophil Cytoplasmic Antibodies (Anca) Class II
FDA product code MOB covers "Test System, Antineutrophil Cytoplasmic Antibodies (Anca)", a Class II medical device regulated under 21 CFR 866.5660. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MOB
- Device Class
- Class II
- Regulation Number
- 866.5660
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243776 | zeus scientific | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplas | May 7, 2025 |
| K172582 | euroimmun us | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte | May 24, 2018 |
| K172461 | aesku.diagnostics gmbh and co. kg | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin | March 23, 2018 |
| K173792 | phadia | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay | March 13, 2018 |
| K161258 | inova diagnostics | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit | February 3, 2017 |
| K140225 | phadia us | ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GB | October 27, 2014 |
| K112545 | inova diagnostics | QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM | July 31, 2012 |
| K100917 | biomedical diagnostics (bmd) | FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM | November 3, 2010 |
| K092601 | immco diagnostics | IMMULISA ANCA SCREEN ELISA | October 7, 2010 |
| K092600 | immco diagnostics | IMMULISA PR3 ANTIBODY ELISA | October 7, 2010 |
| K092599 | immco diagnostics | IMMULISA MPO ANTIBODY ELISA | October 7, 2010 |
| K091859 | aesku diagnostics | AESKU PR3 | June 3, 2010 |
| K091860 | aesku diagnostics | AESKULISA MPO, MODEL 30-7303US | February 23, 2010 |
| K083850 | euroimmun us | EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS | May 20, 2009 |
| K082130 | euroimmun us | EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) | April 7, 2009 |
| K070458 | biomedical diagnostics (bmd) | MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 | December 21, 2007 |
| K060700 | euroimmun us | EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. | September 8, 2006 |
| K061376 | theratest laboratories | EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 | July 20, 2006 |
| K053012 | biomedical diagnostics (bmd) | FIDIS VASCULITIS, MODEL MX007 | March 2, 2006 |
| K051489 | euroimmun us | EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM | February 16, 2006 |