Product code LFX— Microbiology
RUBELLA IGG ELISA TEST
- Classification name
- Enzyme Linked Immunoabsorbent Assay, Rubella
- Device class
- Class 2
- Regulation
- 21 CFR 866.3510
- Advisory panel
- Microbiology
- Total cleared
- 94
- First cleared
- Most recent
Market context for product code LFX
FDA has cleared devices under product code LFX between 1979 and 2025, filed by 50 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- 2025
- 2012
- 2011
- 2010
- 2008
- 2007
- 2006
- 2003
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
Top applicants under product code LFX
Recent clearances under product code LFX
- K250588 — Access Rubella IgG
- K243168 — Alinity i Rubella IgG
- K122397 — LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM
- K093101 — MAGO 4S
- K092587 — BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM
- K092322 — ELECSYS RUBELLA IGM IMMUNOASSAY
- K080766 — VIDAS RUB IGG
- K072617 — ELECSYS RUBELLA IGG IMMUNOASSAY
- K073390 — DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS
- K063186 — ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM
- K063143 — VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS
- K031606 — ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
- K012077 — IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6
- K010668 — BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY
- K003412 — ADVIA CENTAUR RUBELLA IGG ASSAY
- K001875 — DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
- K993291 — COPALIS RUBELLA IGM
- K984180 — THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM
- K983805 — THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
- K981729 — IS-RUBELLA IGG TEST SYSTEM
- K982078 — IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS)
- K982281 — SERAQUEST RUBELLA IGM
- K971304 — QUANTA LITE REBELLA IGG
- K963613 — IMMULITE RUBELLA IGG
- K952721 — RUBASCAN CARD TEST
- K960358 — INCSTAR RUBELLA IGG FAST ELISA ASSAY
- K960367 — INCSTAR RUBELLA IGG ELISA ASSAY
- K954045 — AXSYM RUBELLA IGG ANTIBODY ASSAY
- K961053 — SERAQUEST RUBELLA IGG
- K951541 — IMX RUBELLA IGG
- K954318 — ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY
- K951359 — RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE
- K954687 — ACCESS RUBELLA IGG
- K950227 — RUBELISA (RUBESTAT)
- K941624 — RUBELLA IGG ELISA TEST
- K931059 — IMX RUBELLA IGM ANTIBODY ASSAY
- K925355 — BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST
- K922581 — BARTELS RUBELLA IGM EIA
- K922586 — BARTELS RUBELLA IGG EIA
- K921573 — RUBELLA IGM
- K914028 — RUBELLA IGM ELISA TEST SYSTEM
- K915870 — OPUS RUBELLA TEST SYSTEM
- K915893 — RUBELLA IGG ELISA TEST
- K914420 — ELISA RUBELLA IGM
- K911444 — RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM
- K911393 — RUBENOSTIKA IGG MICROELISA SYSTEM
- K903308 — TRANSTAT-CMV(TM)
- K904084 — RUBELLA IGM ELISA TEST
- K905079 — ORTHO RUBELLA-M ANTIBODY ELISA TEST
- K902571 — MODIFICATION OF SEROCARD RUBELLA IGG TEST
- K902925 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)
- K902793 — RUBELLA IGG
- K901635 — RUBELLA IGG ELISA TEST
- K896479 — ORTHO* RUBELLA-G ANTIBODY ELISA TEST
- K894946 — PLATELIA RUBELLA IGG KIT
- K894546 — IMMUNODOT RUBELLA TEST
- K892202 — DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST
- K894544 — BIOTROL RUB-E.I.A. TEST G
- K883924 — CAPTIA(R) RUBELLA-G
- K885300 — CAPTIA(R) RUBELLA-M
- K891783 — RUBELLA ELISA TEST SYSTEM
- K885295 — IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY
- K885297 — IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY
- K892051 — RUBELLA-CUBE(TM)
- K884247 — MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT
- K884898 — IMMUNODOT TORCH TEST RUBELLA
- K890091 — MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT
- K884617 — ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY
- K885082 — IMMUNODOT RUBELLA TEST
- K882999 — RUBENOSTIKA(TM) IGM MICROELISA SYSTEM
- K883182 — FIAGEN RUBELLA IGG
- K883778 — RUBELLA IGM MICROASSAY
- K882475 — AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200
- K881243 — RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201
- K875368 — THE DDI SERODOT RUBELLA IGG TEST KIT
- K873780 — MODIFICATION RUBELLA IGM EIA TEST KIT
- K873088 — VIRGO(TM) RUBELLA IGG ELISA
- K872071 — CHROMOTITRE E.I.A. RUBELLA IGG
- K864602 — RUBELLA MICROASSAY
- K864315 — CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY
- K862431 — RUBELLA IGM EIA TEST KIT
- K860145 — RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540
- K853696 — RUBELLA IGG EIA TEST KIT
- K861282 — MUREX SUDS RUBELLA
- K854618 — CORDOT R
- K853069 — TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT
- K841200 — RUBELLA IGG ANTIBODY ELISA TEST SYS
- K822342 — ORTHO RUBELLA ELISA TEST SYSTEM
- K821804 — RUBELLA RQ BIO-ENZABEAD KIT
- K813493 — ENZYGNOST TM RUBELLA IGM
- K812787 — EIA RUBELLA
- K803133 — RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL
- K803175 — RUBELLA VIRUS SEROLOGICAL REAGENTS
- K791746 — ROTAZYME
Data sourced from openFDA. This site is unofficial and independent of the FDA.