CFF · Class II · 21 CFR 866.5510

FDA Product Code CFF: Immunoelectrophoretic, Immunoglobulins, (g, A, M)

Leading manufacturers include Sebia, Helena Laboratories and Morax.

29
Total
29
Cleared
141d
Avg days
1979
Since
29 devices
25–29 of 29
Cleared Feb 23, 1993
IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC
K924769
The Binding Site, Ltd.
Immunology · 153d
Cleared Nov 02, 1992
REP IMMUNOFIX
K923658
Helena Laboratories
Immunology · 102d
Cleared Jun 09, 1989
REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178
K892424
Helena Laboratories
Chemistry · 60d
Cleared Mar 07, 1983
PARAGON IMMUNOELECTROPHORESIS REAGENT
K823884
Beckman Instruments, Inc.
Chemistry · 70d
Cleared Jul 24, 1979
CORNING PARAPROTEIN SCREENING
K790667
Corning Medical & Scientific
Immunology · 109d