DHN — Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Class II

FDA Device Classification

Classification Details

Product Code
DHN
Device Class
Class II
Regulation Number
866.5100
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K201956zeus scientificZeus IFA ANA HEp-2 Test System, Zeus dIFineApril 29, 2022
K172745immco diagnosticsImmuGlo HEp-2 Elite IFAJune 5, 2018
K153117aesku systems gmbh and co.kgAESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEMJuly 28, 2016
K160265immuno concepts, n.a.Image Navigator by Immuno ConceptsJune 17, 2016
K141827euroimmun usEUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWAREApril 17, 2015
K150155inova diagnosticsNOVA Lite DAPI ANA KitApril 8, 2015
K131791euroimmun usIFA 40: HEP-20-10February 26, 2014
K120889aesku diagnosticsAESKUSLIDES ANA HEP-2October 15, 2012
K070763euroimmun usEUROIMMUN ANA IFA: HEP-20-10May 22, 2007
K042680corgenixRHIGENE HEP-ANA TEST SYSTEMNovember 19, 2004
K024220bio-radLIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130January 17, 2003
K024229bio-radLIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111January 15, 2003
K024222bio-radLIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112January 15, 2003
K024221bio-radLIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118January 15, 2003
K024225bio-radLIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119January 15, 2003
K024227bio-radLIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127January 15, 2003
K024230bio-radLIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEJanuary 15, 2003
K024224bio-radLIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129January 15, 2003
K024217bio-radLIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108January 15, 2003
K024231bio-radLIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118January 13, 2003