LLL — Extractable Antinuclear Antibody, Antigen And Control Class II
FDA Device Classification
Classification Details
- Product Code
- LLL
- Device Class
- Class II
- Regulation Number
- 866.5100
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250666 | zeus scientific | Alegria Flash CTD Screen | October 22, 2025 |
| K250408 | zeus scientific | Alegria Flash ENA Screen | September 19, 2025 |
| K213403 | inova diagnostics | Aptiva CTD Essential Reagent | September 29, 2023 |
| K190710 | phadia | EliA SymphonyS Immunoassay | November 29, 2019 |
| K180975 | inova diagnostics | QUANTA Flash HMGCR Reagents | June 25, 2018 |
| K152635 | inova diagnostics | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Contro | June 1, 2016 |
| K151429 | inova diagnostics | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrol | February 12, 2016 |
| K142781 | immco diagnostics | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody | March 31, 2015 |
| K141328 | inova diagnostics | QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS | February 12, 2015 |
| K141210 | inova diagnostics | QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS | January 29, 2015 |
| K122923 | inova diagnostics | QUANTA FLASH ENA7 | May 7, 2013 |
| K112996 | euroimmun us | EUROIMMUN ANTI-ENA POOL ELISA (IGG) | April 9, 2013 |
| K113143 | immco diagnostics | IMMULISA SCI-70 ANTIBODY ELISA | December 2, 2011 |
| K102607 | biomedical diagnostics (bmd) | FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS | December 3, 2010 |
| K072149 | phadia us | ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 | January 15, 2008 |
| K053653 | biomedical diagnostics (bmd) | FIDIS CONNECTIVE 10, MODEL MX006 | March 13, 2006 |
| K050286 | biomedical diagnostics (bmd) | FIDIS CONNECTIVE 8 | October 3, 2005 |
| K043067 | bioarray solutions | ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 | May 31, 2005 |
| K041753 | aesku diagnostics | AESKULISA ENA 6 S | July 14, 2004 |
| K040160 | inova diagnostics | QUANTA PLEX SLE PROFILE 8 | March 8, 2004 |