DOE · Class II · 21 CFR 862.3640

FDA Product Code DOE: Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep.

Leading manufacturers include Roche Diagnostic Systems, Inc., Alfa Scientific Designs, Inc. and Hoffmann-La Roche, Inc..

12
Total
12
Cleared
124d
Avg days
1983
Since

FDA 510(k) Cleared Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. Devices (Product Code DOE)

12 devices
1–12 of 12
Cleared May 29, 2001
INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST
K010079
Alfa Scientific Designs, Inc.
Toxicology · 139d
Cleared May 29, 2001
INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST
K010080
Alfa Scientific Designs, Inc.
Toxicology · 139d
Cleared Jun 01, 1995
ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION
K951319
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 09, 1994
ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)
K935055
Roche Diagnostic Systems, Inc.
Toxicology · 293d
Cleared Apr 06, 1994
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
K933572
Immunalysis Corporation
Toxicology · 257d
Cleared Mar 19, 1987
THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT
K863913
Diagnostic Products Corp.
Toxicology · 162d
Cleared Mar 16, 1987
MORPHINE ROCHE (R) EIA TEST
K864168
Roche Diagnostic Systems, Inc.
Toxicology · 143d
Cleared Mar 24, 1983
ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE
K830460
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 24, 1983
ABUSCREEN RADIOUMMUNOASSAY--URINE
K830462
Hoffmann-La Roche, Inc.
Toxicology · 37d

About Product Code DOE - Regulatory Context