Vivachek Biotech (Hangzhou) Co., Ltd.

Code	Device name	Class	Specialty	Clearances	Most recent
NFT	Test, Amphetamine, Over The Counter	Class II	Clinical Toxicology	4	2026-05-22
NBW	System, Test, Blood Glucose, Over The Counter	Class II	Clinical Chemistry	2	2024-08-16
NGL	Test, Opiates, Over The Counter	Class II	Clinical Toxicology	1	2024-10-04
DJG	Enzyme Immunoassay, Opiates	Class II	Clinical Toxicology	1	2024-06-14
NFW	Test, Cannabinoid, Over The Counter	Class II	Clinical Toxicology	1	2023-08-31
JIN	—	—	—	1	2020-06-05

Date	K-number	Device	Code	Class	Specialty
2026-05-22	K261280	BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel	NFT	Class II	Clinical Toxicology
2025-09-12	K252554	Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup	NFT	Class II	Clinical Toxicology
2024-10-04	K241869	BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader	NGL	Class II	Clinical Toxicology
2024-08-16	K222126	VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System	NBW	Class II	Clinical Chemistry
2024-06-14	K240124	BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader	DJG	Class II	Clinical Toxicology
2023-12-22	K233058	VivaChek Link Plus Blood Glucose Monitoring System	NBW	Class II	Clinical Chemistry
2023-11-02	K233062	BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx	NFT	Class II	Clinical Toxicology
2023-08-31	K231978	BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx Marijuana Test Strip 50; BioSieve Dx Marijuana Test Panel 20; BioSieve Dx Marijuana Test Panel 50	NFW	Class II	Clinical Toxicology
2022-11-10	K222667	Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx	NFT	Class II	Clinical Toxicology
2020-06-05	K192957	VivaChek Blood Glucose and B-Ketone Monitoring System	JIN	—	—

Clearance cadence by quarter