Product code DOE— Clinical Toxicology
ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE
- Classification name
- Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
- Device class
- Class 2
- Regulation
- 21 CFR 862.3640
- Advisory panel
- Clinical Toxicology
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code DOE
FDA has cleared devices under product code DOE between 1983 and 2001, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2001
- 2000
- 1995
- 1994
- 1988
- 1987
- 1983
Top applicants under product code DOE
Recent clearances under product code DOE
- K010079 — INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST
- K010080 — INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST
- K011011 — LIVESURE MORPHINE SCREEN TEST
- K002418 — BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D
- K951319 — ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION
- K935055 — ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)
- K933572 — URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
- K881102 — MICROMEDIC MORPHINE RIA KIT
- K863913 — THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT
- K864168 — MORPHINE ROCHE (R) EIA TEST
- K830460 — ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE
- K830462 — ABUSCREEN RADIOUMMUNOASSAY--URINE
Data sourced from openFDA. This site is unofficial and independent of the FDA.