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
Clearances under product code LLL — page 2
101–182 of 182- K935419 — LA EIA TEST KIT
- K935828 — HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
- K935129 — RELISA ENA ANTIBODY SCREENING TEST SYSTEM
- K934053 — QUANTA LITE(TM) HISTONE ELISA
- K932877 — DIASTAT ANTI-CENTROMERE KIT
- K932850 — ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN
- K931543 — ENCORE ENA COMBINED EIA
- K932419 — ANTI-SS-B/LA ANTIBODY TEST
- K931495 — ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT
- K924945 — ELISA-DPXA SSA KIT
- K924946 — ELISA-DOXA SSB
- K924947 — ELISA-DOXA SM
- K924948 — ELISA-DOXA SM/RNP
- K924949 — ELISA-DOXA SCL-70
- K924950 — ELISA-DOXA JO-1
- K924951 — ELISA-DOXA COMBI-4
- K924952 — ELISA-DOXA COMBI-6
- K930281 — SYNELISA JO-1 ANTIBODIES
- K930417 — SYNELISA SCL-70 ANTIBODIES
- K930757 — RHEUMELISA II JO-1 ANTIBODY TEST KIT
- K930130 — RHEUMELISA II SCL-70 ANTIBODY TEST KIT
- K926562 — QUANTA LITE(TM) JO-1 ELISA KIT
- K925118 — EN TYPING CIE KIT FOR DIAGNOSTIC USE
- K924262 — ENA SCREENING CIE KIT FOR DIAGNOSTIC USE
- K924898 — QUANTA LITE(TM) SCL-70 ELISA
- K921572 — ENCORE SM
- K921870 — ENCORE SM/RNP
- K924843 — IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL
- K922241 — AUTOZYME
- K922340 — ENCORE SS-B
- K922157 — ENCORE SS-A
- K922829 — QUANTA LITE ENA ELISA
- K922830 — QUANTA LITE SS-A ELISA
- K922831 — QUANTA LITE SM ELISA
- K922832 — QUANTA LITE SS-B ELISA
- K922833 — QUANTA LITE RNP ELISA
- K915420 — HEMAGEN ENA [JO-1] KIT (EIA METHOD)
- K920383 — ANTI-ENA ANTIBODY TEST [SS-A (RO)]
- K920384 — ANIT-ENA ANTIBODY TEST [SS-B (LA)]
- K920385 — ANTI-ENA ANTIBODY TEST (SM)
- K920386 — ANTI-ENA ANTIBODY TEST KIT
- K915282 — HEMAGEN ENA SCL-70 KIT (EIA METHOD)
- K915058 — HEMAGEN ENA SCREENING KIT (EIA METHOD)
- K915234 — HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)
- K913041 — ANTI-DSDNA ANTIBODY TEST
- K911679 — ANTI-JO-1 MICROASSAY
- K910232 — HEMAGEN ENA SCREENING KIT
- K903898 — QUANTA LITE TM DSDNA
- K903314 — ANTI-SCI-70 ANTIBODY TEST
- K902938 — IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3
- K903047 — IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4
- K901924 — READS(R) ANTI-ENA (SM/RNP) TEST KIT
- K901230 — REAADS ANTI-SM TEST KIT
- K901073 — ANTI-RNP MICROASSAY
- K900617 — SERATEST ENA [SSA] KIT
- K900241 — ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY
- K896459 — NOVA GEL(TM) T SM/RNP
- K896460 — NOVA GEL(TM) T SS-A/SS-B
- K896461 — NOVA GEL(TM) T SCL-70
- K896462 — NOVA GEL(TM) T JO-1
- K895339 — ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST
- K892897 — NOVA GEL(TM) JO-1
- K881341 — NOVA LITE(TM) SA
- K883232 — HISTONE REACTIVE ANA
- K881340 — NOVA LITE(TM) AUTOANTIBODY CONTROLS
- K880897 — NOVA GEL (TM) SCL-70
- K881339 — NOVA LITE(TM) ANA PLUS
- K881181 — NOVA GEL(TM) SM/RNP
- K880736 — NOVA LITE(TM) ANA
- K880896 — NOVA GEL(TM) SS-A/SS-B
- K873708 — FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES
- K871994 — ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)
- K862700 — SERATEST ENA [SS-B] KIT
- K862710 — KALLESTAD SSA/SSB ENA TEST REAGENTS
- K860428 — SM-RNP AUTOANTIBODY TEST SYSTEM
- K860644 — SS-A/SS-B AUTOANTIBODY TEST SYSTEM
- K843423 — PHYSIO GAS ANALYZER
- K844743 — SERATEST ENA(RNP/SM) DETERMINATION
- K843978 — ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY
- K840221 — EXTRACTABLE NUCLEAR ANTIGEN ASSAY
- K831036 — ENA TEST KIT SM & RNP AUTO ANTIBODY
- K810592 — NUCLEAR ANTIGENS
Data sourced from openFDA. This site is unofficial and independent of the FDA.