NWM
2021-08-05
Immunoassay, Anti-Seizure Drug
FDA product code NWM · 5 cleared devices
Class 2
Clinical Toxicology
- Regulation
- 21 CFR 862.3350
- Review panel
- TX
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 2005-11-18 – 2021-08-05
To aid in management of patients treated with anti-seizure drug.
NWM
2009-12-09
ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003
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NWM
2009-04-16
TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00
View details →
NWM
2007-05-17
SERADYN QMS TOPIRAMATE
View details →
NWM
2005-11-18
QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
View details →No matching devices.
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