Source: https://casetext.com/regulation/code-of-federal-regulations/title-21-food-and-drugs/chapter-i-food-and-drug-administration-department-of-health-and-human-services-continued/subchapter-h-medical-devices/part-862-clinical-chemistry-and-clinical-toxicology-devices/subpart-d-clinical-toxicology-test-systems/8623150-barbiturate-test-system?ref=AsVVwS!36j0C8
Timestamp: 2020-02-20 00:17:26
Document Index: 290448530

Matched Legal Cases: ['§ 862', '§ 862', 'ART 862', '§ 862', '§ 862', 'art 807', '§ 862', '§ 862', '§ 862']

§ 862.3150 Barbiturate test system, 21 C.F.R. § 862.3150 | Casetext
Title 21 - Food and DrugsCHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)SUBCHAPTER H - MEDICAL DEVICESPART 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart D - Clinical Toxicology Test Systems
§ 862.3150 Barbiturate test system
21 C.F.R. § 862.3150
(b) Classification. Class II (special controls). A barbiturate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g, programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
§ 862.3120 Arsenic test system
§ 862.3170 Benzodiazepine test system