LFX — Enzyme Linked Immunoabsorbent Assay, Rubella Class II
FDA product code LFX covers "Enzyme Linked Immunoabsorbent Assay, Rubella", a Class II medical device regulated under 21 CFR 866.3510. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LFX
- Device Class
- Class II
- Regulation Number
- 866.3510
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250588 | beckman coulter | Access Rubella IgG | November 17, 2025 |
| K243168 | abbott laboratories | Alinity i Rubella IgG | June 20, 2025 |
| K122397 | diasorin | LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM | September 6, 2012 |
| K093101 | diamedix | MAGO 4S | January 21, 2011 |
| K092587 | bio-rad laboratories | BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION S | December 3, 2010 |
| K092322 | roche diagnostics | ELECSYS RUBELLA IGM IMMUNOASSAY | March 12, 2010 |
| K080766 | biomerieux | VIDAS RUB IGG | December 23, 2008 |
| K072617 | roche diagnostics | ELECSYS RUBELLA IGG IMMUNOASSAY | December 5, 2008 |
| K073390 | diasorin | DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS | November 21, 2008 |
| K063186 | zeus scientific | ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM | March 21, 2007 |
| K063143 | ortho-clinical diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS | December 26, 2006 |
| K031606 | beckman coulter | ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY | June 20, 2003 |
| K012077 | diagnostic products | IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KR | January 10, 2002 |
| K010668 | bayer | BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY | July 5, 2001 |
| K003412 | bayer | ADVIA CENTAUR RUBELLA IGG ASSAY | April 13, 2001 |
| K001875 | diamedix | DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM | August 21, 2000 |
| K993291 | diasorin | COPALIS RUBELLA IGM | February 10, 2000 |
| K984180 | zeus scientific | THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM | July 20, 1999 |
| K983805 | zeus scientific | THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYM | May 26, 1999 |
| K981729 | diamedix | IS-RUBELLA IGG TEST SYSTEM | January 28, 1999 |