Extractable Antinuclear Antibody, Antigen And Control
FDA product code LLL · 179 cleared devices
Class 2
Immunology
- Regulation
- 21 CFR 866.5100
- Review panel
- IM
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1981-10-23 – 2026-08-21
LLL
1993-12-21
LLL
1993-10-15
DIASTAT ANTI-CENTROMERE KIT
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LLL
1993-09-24
ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN
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LLL
1993-09-08
ENCORE ENA COMBINED EIA
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LLL
1993-08-05
ANTI-SS-B/LA ANTIBODY TEST
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LLL
1993-07-16
ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT
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LLL
1993-05-19
ELISA-DOXA COMBI-6
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LLL
1993-05-19
ELISA-DOXA COMBI-4
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LLL
1993-05-19
ELISA-DOXA JO-1
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LLL
1993-05-19
ELISA-DOXA SCL-70
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LLL
1993-05-19
ELISA-DOXA SM/RNP
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LLL
1993-05-19
ELISA-DOXA SM
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LLL
1993-05-19
ELISA-DOXA SSB
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LLL
1993-05-19
ELISA-DPXA SSA KIT
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LLL
1993-04-06
SYNELISA SCL-70 ANTIBODIES
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LLL
1993-04-06
SYNELISA JO-1 ANTIBODIES
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LLL
1993-03-26
RHEUMELISA II JO-1 ANTIBODY TEST KIT
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LLL
1993-03-23
RHEUMELISA II SCL-70 ANTIBODY TEST KIT
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LLL
1993-03-04
QUANTA LITE(TM) JO-1 ELISA KIT
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LLL
1993-02-02
EN TYPING CIE KIT FOR DIAGNOSTIC USE
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LLL
1992-12-29
ENA SCREENING CIE KIT FOR DIAGNOSTIC USE
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LLL
1992-12-15
QUANTA LITE(TM) SCL-70 ELISA
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LLL
1992-12-01
IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL
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LLL
1992-12-01
ENCORE SM/RNP
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LLL
1992-12-01
ENCORE SM
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LLL
1992-11-30
AUTOZYME
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LLL
1992-10-16
ENCORE SS-B
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LLL
1992-10-13
ENCORE SS-A
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LLL
1992-09-18
QUANTA LITE RNP ELISA
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LLL
1992-09-18
QUANTA LITE SS-B ELISA
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LLL
1992-09-18
QUANTA LITE SM ELISA
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LLL
1992-09-18
QUANTA LITE SS-A ELISA
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LLL
1992-09-18
QUANTA LITE ENA ELISA
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LLL
1992-04-07
HEMAGEN ENA [JO-1] KIT (EIA METHOD)
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LLL
1992-03-30
ANTI-ENA ANTIBODY TEST KIT
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LLL
1992-03-30
ANTI-ENA ANTIBODY TEST (SM)
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LLL
1992-03-30
ANIT-ENA ANTIBODY TEST [SS-B (LA)]
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LLL
1992-03-30
ANTI-ENA ANTIBODY TEST [SS-A (RO)]
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LLL
1992-02-12
HEMAGEN ENA SCL-70 KIT (EIA METHOD)
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LLL
1991-12-20
HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)
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LLL
1991-12-20
HEMAGEN ENA SCREENING KIT (EIA METHOD)
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LLL
1991-11-05
ANTI-DSDNA ANTIBODY TEST
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LLL
1991-09-23
ANTI-JO-1 MICROASSAY
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LLL
1991-03-06
HEMAGEN ENA SCREENING KIT
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LLL
1990-09-05
QUANTA LITE TM DSDNA
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LLL
1990-08-14
ANTI-SCI-70 ANTIBODY TEST
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LLL
1990-08-09
IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4
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LLL
1990-08-09
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3
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LLL
1990-05-09
READS(R) ANTI-ENA (SM/RNP) TEST KIT
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LLL
1990-03-23
REAADS ANTI-SM TEST KIT
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LLL
1990-03-19
ANTI-RNP MICROASSAY
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LLL
1990-02-23
SERATEST ENA [SSA] KIT
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LLL
1990-02-02
ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY
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LLL
1989-11-20
NOVA GEL(TM) T JO-1
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LLL
1989-11-20
NOVA GEL(TM) T SCL-70
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LLL
1989-11-20
NOVA GEL(TM) T SS-A/SS-B
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LLL
1989-11-20
NOVA GEL(TM) T SM/RNP
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LLL
1989-10-04
ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST
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LLL
1989-05-17
NOVA GEL(TM) JO-1
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LLL
1988-09-22
NOVA LITE(TM) SA
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LLL
1988-09-07
HISTONE REACTIVE ANA
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LLL
1988-06-08
NOVA LITE(TM) AUTOANTIBODY CONTROLS
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LLL
1988-04-21
NOVA LITE(TM) ANA PLUS
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LLL
1988-04-21
NOVA GEL (TM) SCL-70
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LLL
1988-04-06
NOVA GEL(TM) SM/RNP
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LLL
1988-03-25
NOVA GEL(TM) SS-A/SS-B
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LLL
1988-03-25
NOVA LITE(TM) ANA
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LLL
1987-11-25
FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES
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LLL
1987-08-12
ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)
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LLL
1986-08-19
SERATEST ENA [SS-B] KIT
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LLL
1986-07-29
KALLESTAD SSA/SSB ENA TEST REAGENTS
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LLL
1986-05-15
SM-RNP AUTOANTIBODY TEST SYSTEM
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LLL
1986-03-28
SS-A/SS-B AUTOANTIBODY TEST SYSTEM
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LLL
1985-02-26
PHYSIO GAS ANALYZER
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LLL
1985-02-04
SERATEST ENA(RNP/SM) DETERMINATION
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LLL
1984-12-18
ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY
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LLL
1984-05-22
EXTRACTABLE NUCLEAR ANTIGEN ASSAY
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LLL
1983-04-27
ENA TEST KIT SM & RNP AUTO ANTIBODY
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LLL
1981-10-23
NUCLEAR ANTIGENS
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