Product code MOB— Immunology
AESKU PR3
- Classification name
- Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Total cleared
- 75
- First cleared
- Most recent
Market context for product code MOB
FDA has cleared devices under product code MOB between 1995 and 2026, filed by 28 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2018
- 2017
- 2014
- 2012
- 2010
- 2009
- 2007
- 2006
- 2005
- 2004
- 2001
- 2000
- 1999
Top applicants under product code MOB
Recent clearances under product code MOB
- K261466 — Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM
- K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
- K172582 — EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern
- K172461 — AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
- K173792 — EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
- K161258 — NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
- K140225 — ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
- K112545 — QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
- K100917 — FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM
- K092599 — IMMULISA MPO ANTIBODY ELISA
- K092600 — IMMULISA PR3 ANTIBODY ELISA
- K092601 — IMMULISA ANCA SCREEN ELISA
- K091859 — AESKU PR3
- K091860 — AESKULISA MPO, MODEL 30-7303US
- K083850 — EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS
- K082130 — EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)
- K070458 — MODIFICATION TO FIDIS VASCULITIS, MODEL MX007
- K060700 — EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.
- K061376 — EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
- K053012 — FIDIS VASCULITIS, MODEL MX007
- K051489 — EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM
- K051455 — WIESLAB CAP MPO-ANCA
- K051458 — WIESLAB CAP PR-3 ANCA
- K050715 — QUANTA PLEX ANCA PROFILE
- K041043 — VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
- K041040 — VARELISA MPO ANCA, MODEL 17648/17696
- K040111 — ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
- K040711 — MESACUP TEST PR-3
- K040586 — MESACUP TEST MPO, MODEL 11053
- K013283 — RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
- K013285 — RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
- K010287 — SCIMEDX PHASE II PR3 IGG ANTIBODY EIA
- K010289 — SCIMEDX PHASE II MPO IGG ANTIBODY EIA
- K002215 — AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
- K001127 — ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY
- K990796 — AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA
- K984516 — THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET
- K984315 — THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE
- K982898 — IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM
- K984034 — THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K983390 — IS-ANTI-MPO IGG ELISA TEST SYSTEM
- K983740 — IS-ANTI-PR3 IGG ELISA TEST SYSTEM
- K981748 — WIELISA ANCA SCREENING KIT TEST SYSTEM
- K981750 — WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM
- K981029 — BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT
- K981030 — BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT
- K981328 — QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT
- K981330 — QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT
- K974166 — WIELISA MPO ANCA TEST SYSTEM
- K974167 — WIELISA PR-3 ANCA TEST SYSTEM
- K974701 — ORGENTEC ANTI-MPO (P-ANCA) ELISA
- K974702 — ORGENTEC ANTI-PR3 (C-ANCA) ELISA
- K974463 — IMMUNO CONCEPTS ANCA TEST SYSTEM
- K974478 — IMMUNO CONCEPTS ANCA TEST SYSTEMS
- K973822 — VIRGO ANCA SCREEN KIT
- K973823 — PR 3 ANTIBODY KIT
- K973824 — VIRGO PANCO KIT
- K971689 — IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT
- K971690 — IMMUNOSCAN PR3-ANCA
- K965133 — ANCA COMBI DIAGNOSTIC TEST KIT
- K964446 — MYELOPEROXIDASE ELISA TEST SYSTEM
- K964448 — PROTEINASE-3 IGG ELISA TEST SYSTEM
- K964449 — ANCA SCREEN ELISA TEST SYSTEM
- K962360 — IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES
- K961764 — PR-3 ELISA TEST SYSTEM
- K961765 — MPO ELISA TEST SYSTEM
- K961340 — NOVA LITE ANCA
- K954062 — EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES
- K954105 — EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES
- K955021 — QUANTA LITE PR3
- K955022 — QUANTA LITE MPO
- K953586 — VARELISA PR3-ANCA
- K953587 — VARELISA MPO-ANCA
- K942813 — DIASTAT ANTI-PR3 (C-ANCA) KIT
- K943630 — DIASTAT ANTI-MPO (PANCA) KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.