Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008741972

FEI Number

3008741972

Entity Name

Lochness Medical

City/State/Country

Buffalo, NY, US

Establishment Address

2775 Broadway, Buffalo, NY 14227, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

BTNX Inc. (Owner Number: 9058575)

Owner / Operator Contact Address

722 Rosebank Road, PICKERING, CA-ON L1W 4B2, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233062

PMA Number

N/A

All Registered Proprietary Names

Rapid Response Drug Test Panel Rapid Response Home Drug Test Cup Rapid Response Home Drug Test Panel Rapid Response Drug Test Cup Rapid Response Home Drug Monitoring Cup Rapid Response Drug Monitoring Cup Rapid Response Drug Monitoring Panel Rapid Response Home Drug Monitoring Panel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2025-07-08
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2025-07-08
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2025-07-08
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2025-07-08
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2025-07-08
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2025-07-08
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2025-07-08
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2025-07-08
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2025-07-08
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2025-07-08
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2025-07-08
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2025-09-12
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2025-09-12
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2025-09-12
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2025-09-12
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2025-09-12
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2025-09-12
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2025-09-12
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2025-09-12
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2025-09-12
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2025-09-12
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2025-09-12
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2025-09-09
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2025-09-09
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2025-09-09
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2025-09-09
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2025-09-09
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2025-09-09
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2025-09-09
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2025-09-09
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2025-09-09
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2025-09-09
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2025-09-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BTNX Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003917514	BTNX Inc.	Pickering Ontario, CA

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K241741	Guangzhou Wondfo Biotech Co., Ltd.	SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel	2024-07-16
K252550	Guangzhou Wondfo Biotech Co., Ltd.	SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx	2025-11-18
K202567	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx	2020-09-25
K260065	Guangzhou Wondfo Biotech Co., Ltd.	SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx	2026-04-28
K182701	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo T-Cup Multi-Drug Urine Test Cup	2018-12-03

Similar Registrations

Registration Number	Establishment Name	Location
3003917514	BTNX Inc.	Pickering Ontario, CA
3009585529	ASSURE TECH. (HANGZHOU) CO., LTD.	Hangzhou Zhejiang, CN
3024463179	ACESO LABORATORIES INC.	Chino, CA, US
3043127647	Hangzhou AllTest Biotech Co.,Ltd	Hangzhou Zhejiang, CN
3008517993	ZHEJIANG ORIENT GENE BIOTECH	Huzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008741972. Last updated year: 2026. Please use registration number 3008741972 when referencing this establishment in official correspondence.