| K201956 | zeus scientific | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | April 29, 2022 |
| K172745 | immco diagnostics | ImmuGlo HEp-2 Elite IFA | June 5, 2018 |
| K153117 | aesku systems gmbh and co.kg | AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM | July 28, 2016 |
| K160265 | immuno concepts, n.a. | Image Navigator by Immuno Concepts | June 17, 2016 |
| K141827 | euroimmun us | EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE | April 17, 2015 |
| K150155 | inova diagnostics | NOVA Lite DAPI ANA Kit | April 8, 2015 |
| K131791 | euroimmun us | IFA 40: HEP-20-10 | February 26, 2014 |
| K120889 | aesku diagnostics | AESKUSLIDES ANA HEP-2 | October 15, 2012 |
| K070763 | euroimmun us | EUROIMMUN ANA IFA: HEP-20-10 | May 22, 2007 |
| K042680 | corgenix | RHIGENE HEP-ANA TEST SYSTEM | November 19, 2004 |
| K024220 | bio-rad | LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 | January 17, 2003 |
| K024229 | bio-rad | LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111 | January 15, 2003 |
| K024222 | bio-rad | LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 | January 15, 2003 |
| K024221 | bio-rad | LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 | January 15, 2003 |
| K024225 | bio-rad | LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 | January 15, 2003 |
| K024227 | bio-rad | LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 | January 15, 2003 |
| K024230 | bio-rad | LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLE | January 15, 2003 |
| K024224 | bio-rad | LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 | January 15, 2003 |
| K024217 | bio-rad | LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 | January 15, 2003 |
| K024231 | bio-rad | LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118 | January 13, 2003 |