Product code LLL— Immunology
HEMAGEN ENA SCL-70 KIT (EIA METHOD)
- Classification name
- Extractable Antinuclear Antibody, Antigen And Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Total cleared
- 182
- First cleared
- Most recent
Market context for product code LLL
FDA has cleared devices under product code LLL between 1981 and 2026, filed by 45 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- 2026
- 2025
- 2023
- 2019
- 2018
- 2016
- 2015
- 2013
- 2011
- 2010
- 2008
- 2006
- 2005
- 2004
- 2003
Top applicants under product code LLL
Recent clearances under product code LLL
1–100 of 182- K253817 — IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La
- K253367 — EliA CTD 13 Screen
- K250666 — Alegria Flash CTD Screen
- K250408 — Alegria Flash ENA Screen
- K213403 — Aptiva CTD Essential Reagent
- K190710 — EliA SymphonyS Immunoassay
- K180975 — QUANTA Flash HMGCR Reagents
- K152635 — QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls
- K151429 — QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols
- K142781 — ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA
- K141328 — QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS
- K141210 — QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS
- K122923 — QUANTA FLASH ENA7
- K112996 — EUROIMMUN ANTI-ENA POOL ELISA (IGG)
- K113143 — IMMULISA SCI-70 ANTIBODY ELISA
- K102607 — FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS
- K072149 — ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01
- K053653 — FIDIS CONNECTIVE 10, MODEL MX006
- K050286 — FIDIS CONNECTIVE 8
- K043067 — ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400
- K041753 — AESKULISA ENA 6 S
- K040160 — QUANTA PLEX SLE PROFILE 8
- K033528 — MESACUP-2 TEST JO-1, MODEL 10756
- K032469 — AESKULISA ANA 8PRO
- K031450 — QUANTA PLEX ENA PROFILE 6
- K030681 — QUANTA PLEX ENA PROFILE 5
- K011140 — QUANTA PLEX ENA PROFILE 4
- K010146 — ENA EIA KIT RANGE
- K010147 — ENA EIA KIT
- K010148 — ENA SCREEN EIA KIT
- K003054 — AUTOSTAT II ENA-6 PROFILE ELISA
- K003057 — AUTOSTAT II ENA-4 PROFILE ELISA
- K000749 — RHIGENE MESACUP2 TEST- SSA
- K000750 — RHIGENE MESACUP2 TEST- SCL-70
- K000751 — RHIGENE MESACUP2 TEST- SSB
- K000489 — ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
- K993839 — ENA PROFILE ELISA TEST SYSTEM
- K993971 — MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM
- K994029 — MDI SM TEST
- K991657 — QUANTA LITE ANA ELISA
- K990626 — AUTOSTAT II ANTI-SS-B/LA ELISA
- K990627 — AUTOSTAT II ANTI-SS-A/RO ELISA
- K990797 — AUTOSTAT II ANTI-SCL-70 ELISA
- K990798 — AUTOSTAT II ANTI-JO-1 ELISA
- K983921 — AUTOSTAT II ENA SCREEN ELISA
- K984462 — LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206
- K983376 — THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S
- K983423 — THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K983425 — THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET
- K983426 — THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC
- K983464 — THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K982603 — QUANTA LITE CHROMATIN ELISA
- K982150 — EL-ANA PROFILES: EL-ENA/4
- K982622 — EL-ANA PROFILES: EL-ENA/5
- K981857 — QUANTA LITE TPO ELISA
- K980639 — SERAQUEST ANTI-SSB
- K980759 — DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM
- K964787 — MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM
- K970218 — IS-ANTI-SSA TEST SYSTEM
- K970220 — IS-ANTI-SM TEST SYSTEM
- K970228 — IS-ANTI-JO-1 TEST SYSTEM
- K970237 — IS-ANTI-SSB TEST SYSTEM (720-260)
- K970238 — IS-ANTI-SM/RNP (720-270)
- K970239 — IS-ANTI-SCL-70 TEST SYSTEM (720-280)
- K962578 — HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY
- K962719 — HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY
- K962720 — HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY
- K962722 — HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY
- K962727 — HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY
- K962728 — HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY
- K962731 — HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY
- K963275 — RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM
- K961913 — QUANTA LITE ENA 6 ELISA
- K955602 — RELSIA SCL-70 ANTIBODY TEST SYSTEM
- K955603 — RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM
- K955604 — RELISA SM/RNP ANTIBODY TEST SYSTEM
- K955605 — RELISA JO-1 ANTIBODY TEST SYSTEM
- K954894 — HYTEC AUTOIMMUNE KITS (SCL-70)
- K954895 — HYTEC AUTOIMMUNE KIT (JO-1)
- K955133 — ORGENTEC ENASCREEN PIN IMMUNO ASSAY
- K955134 — ORGENTEC ENASCREEN ELISA ASSAY
- K954890 — HYTEC AUTOMMUNE KIT (ENA)
- K952253 — ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT
- K952076 — HEMAGEN ENA SCREENING KIT (EIA METHOD)
- K952077 — HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
- K950414 — HEMAGEN ENA SM/RMP KIT (EIA METHOD)
- K946120 — HEMAGEN ENA SS-B KIT (EIA METHOD)
- K946121 — HEMAGEN ENA SS-A KIT (EIA METHOD)
- K946122 — HEMAGEN ENA SCL-70 KIT (EIA METHOD)
- K946123 — HEMAGEN ENA SM KIT (EIA METHOD)
- K946124 — HEMAGEN ENA JO-1 KIT (EIA METHOD)
- K943291 — ANTI DS-DNA
- K944505 — DIASTAT ENA SINGLE WELL SCREEN KIT
- K943076 — QUANTA LITE ENA 5 ELISA KIT
- K940362 — ANA SCREEN ELISA TEST SYSTEM
- K935413 — ENA EIA TEST KIT
- K940229 — SYN ENA SCREEN (PIN PLATE)
- K940622 — ELIAS ENA SCREEN (MICROTITER PLATE)
- K935417 — JO-1 EIA TEST KIT
- K935418 — SCL-70 EIA TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.