JIR · Class I · 21 CFR 862.1645

FDA Product Code JIR: Indicator Method, Protein Or Albumin (urinary, Non-quant.)

Leading manufacturers include Bayer Corp., Boehringer Mannheim Corp. and Biotrol, USA, Inc..

38
Total
38
Cleared
146d
Avg days
1981
Since
38 devices
25–38 of 38
Cleared Jul 19, 1991
MICRO ALBUMIN EIA TEST KIT
K912543
Immuno Diagnostic Center, Inc.
Chemistry · 39d
Cleared Apr 12, 1991
CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS
K904752
Boehringer Mannheim Corp.
Chemistry · 175d
Cleared Aug 22, 1990
STANBIO CSF/URINE TOTAL PROTEIN TEST SET
K902204
Stanbio Laboratory
Chemistry · 98d
Cleared Feb 16, 1990
KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT
K896440
Kenlor Industries, Inc.
Chemistry · 99d
Cleared Sep 18, 1989
BIOTEL MICROALBUMINURIA (TM)
K894169
American Diagnostic Corp.
Chemistry · 95d
Cleared Jun 09, 1989
DIALBUMIN
K891544
Exocell, Inc.
Chemistry · 84d
Cleared Mar 21, 1989
BIOTROL URINE PROTEINS REAGENT
K890846
Biotrol, USA, Inc.
Chemistry · 28d
Cleared Mar 13, 1989
PROGENE MICROALBUMINURIA SCREEN
K882538
Progene Corp.
Chemistry · 265d
Cleared Jan 30, 1989
BIOTROL URINE PROTEINS REAGENT
K885053
Biotrol, USA, Inc.
Chemistry · 54d
Cleared Jan 23, 1989
ALBUWELL
K884146
Exocell, Inc.
Chemistry · 112d
Cleared Apr 28, 1988
MICRO-BUMINTEST REAGENT TABLETS
K874909
Miles Laboratories, Inc.
Chemistry · 149d
Cleared Apr 07, 1986
DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI
K851338
Diagnostic Products Corp.
Chemistry · 369d
Cleared Apr 28, 1983
HELENA BIOSTRIP P
K830977
Helena Laboratories
Chemistry · 30d
Cleared May 21, 1981
KOVA STRIP 6
K811219
Icl Scientific
Microbiology · 17d