FDA Product Code LLL: Extractable Antinuclear Antibody, Antigen And Control
Leading manufacturers include Inova Diagnostics, Inc., Hemagen Diagnostics, Inc. and Diamedix Corp..
182
Total
182
Cleared
110d
Avg days
1981
Since
182 devices
Cleared
Mar 25, 1988
NOVA LITE(TM) ANA
Inova Diagnostics, Inc.
Immunology
30d
Cleared
Mar 25, 1988
NOVA GEL(TM) SS-A/SS-B
Inova Diagnostics, Inc.
Immunology
23d
Cleared
Nov 25, 1987
FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES
Whittaker Bioproducts, Inc.
Immunology
71d
Cleared
Aug 12, 1987
ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)
Behring Diagnostics, Inc.
Immunology
78d
Cleared
Aug 19, 1986
SERATEST ENA [SS-B] KIT
Hemagen Diagnostics, Inc.
Immunology
35d
Cleared
Jul 29, 1986
KALLESTAD SSA/SSB ENA TEST REAGENTS
Kallestad Laboratories, Inc.
Immunology
13d
Cleared
May 15, 1986
SM-RNP AUTOANTIBODY TEST SYSTEM
Immuno Concepts, Inc.
Immunology
100d
Cleared
Mar 28, 1986
SS-A/SS-B AUTOANTIBODY TEST SYSTEM
Immuno Concepts, Inc.
Immunology
36d
Cleared
Feb 26, 1985
PHYSIO GAS ANALYZER
Research Medical, Inc.
Immunology
179d
Cleared
Feb 04, 1985
SERATEST ENA(RNP/SM) DETERMINATION
Seragen Diagnostics, Inc.
Immunology
61d
Cleared
Dec 18, 1984
ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY
Behring Diagnostics, Inc.
Immunology
68d
Cleared
May 22, 1984
EXTRACTABLE NUCLEAR ANTIGEN ASSAY
Zeus Scientific, Inc.
Microbiology
124d
Cleared
Apr 27, 1983
ENA TEST KIT SM & RNP AUTO ANTIBODY
Calbiochem-Behring Corp.
Immunology
27d
Cleared
Oct 23, 1981
NUCLEAR ANTIGENS
Alpha Antigens, Inc.
Immunology
232d