Anti-Rnp Antibody, Antigen And Control
FDA product code LKO · 22 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
- 1983-07-18 – 2019-10-25
LKO
2019-10-25
LKO
2013-06-12
EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
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LKO
2009-05-28
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
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LKO
2007-12-19
MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
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LKO
2002-08-14
RHIGENE MESACUP-2 TEST RNP, MODEL M7741
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LKO
2000-05-09
RHIGENE MESACUP2 TEST- RNP
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LKO
1999-11-26
VARELISA RNP ANTIBODIES
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LKO
1999-04-28
AUTOSTAT II ANTI-SM/RNP ELISA
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LKO
1998-12-22
LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207
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LKO
1998-11-18
THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
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LKO
1996-05-08
ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY
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LKO
1996-03-22
HYTEC AUTOIMMUNE KITS (RNP)
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LKO
1994-04-20
ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT
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LKO
1993-05-11
SYNELISA U1-SNRNP (68KDA)-ANTIBODIES
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LKO
1991-05-07
IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST
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LKO
1991-05-07
IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST
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LKO
1990-12-13
DIASTAT ANTI-RO (SS-A)
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LKO
1990-12-13
DIASTAT ANTI-LA (SS-B)
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LKO
1989-11-06
RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES
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LKO
1989-10-17
ANTI-RNP AND ANTI-SM ANTIBODY TEST
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LKO
1988-03-11
RNP ANTIBODY TEST KIT
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LKO
1983-07-18
ANTI-ENA TEST
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