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 Teco Diagnostics.

38

Total

38

Cleared

146d

Avg days

1981

Since

38 devices

25–38 of 38

Cleared Sep 18, 1989

BIOTEL MICROALBUMINURIA (TM)

American Diagnostic Corp.

Chemistry · 95d

Cleared Mar 21, 1989

BIOTROL URINE PROTEINS REAGENT

Biotrol, USA, Inc.

Chemistry · 28d

Cleared Jan 30, 1989

BIOTROL URINE PROTEINS REAGENT

Biotrol, USA, Inc.

Chemistry · 54d

Cleared Apr 28, 1988

MICRO-BUMINTEST REAGENT TABLETS

Miles Laboratories, Inc.

Chemistry · 149d

Cleared Apr 07, 1986

DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI

Diagnostic Products Corp.

Chemistry · 369d

Cleared Apr 28, 1983

HELENA BIOSTRIP P

Helena Laboratories

Chemistry · 30d

Cleared May 21, 1981

Microbiology · 17d