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Enzyme Immunoassay, Amphetamine

FDA product code DKZ · 212 cleared devices

Class 2 Clinical Toxicology
Regulation
21 CFR 862.3100
Review panel
TX
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1976-08-03 – 2024-10-30
DKZ 2019-03-27

Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)

Applicant Hangzhou AllTest Biotech Co., Ltd.

K number K182738

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