Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030648160

FEI Number

3030648160

Entity Name

ASSURE TECH LLC

City/State/Country

Wilmington, DE, US

Establishment Address

1521 Concord Pike Suite 201, Wilmington, DE 19803, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Assure Tech LLC (Owner Number: 10090182)

Owner / Operator Contact Address

1521 Concord Pike Suite 201, Wilmington, DE 19803, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Rapid Diagnostic Tests Rapid Diagnostic Tests Ketones Urinary Test FaStep Pregnancy Rapid Test Cassette Fastep HCG Rapid Test Cassette AssureTech Quick Cup Tests AssureTech Multi-drug Urine Test Cup AssureTech Multi-drug Urine Test Panel AssureTech Panel Dip Tests Rapid Diagnostic Tests HealCare LH Ovulation Rapid Test OvaMate Fertility Predictor kit (With OvaMate APP) Rapid Diagnostic Tests Rapid Diagnostic Tests Rapid Diagnostic Tests Rapid Diagnostic Tests Vitamin C Urinary Test Rapid Diagnostic Tests Fastep COVID-19 Antigen Pen Home Test Fastep COVID-19 Antigen Pen Test Rapid Diagnostic Tests Rapid Diagnostic Tests FaStepTM Fentanyl Rapid Test Device FaStepTM Rapid Fentanyl Urine Test Rapid Diagnostic Tests Rapid Diagnostic Tests HealCare HCG Pregnancy Rapid Test HealCare HCG Pregnancy Rapid Test Midstream Rapid Diagnostic Tests Rapid Diagnostic Tests Nitric Oxide Indicator Strip Nitrite Urinary Test Rapid Diagnostic Tests OvaMate Menopause Predictor kit (With OvaMate APP) HealCare FSH Menopause Rapid Test AssureTech Multi-drug Urine Test Cup AssureTech Quick Cup Tests Rapid Diagnostic Tests Rapid Diagnostic Tests Breath Alcohol Test Rapid Diagnostic Tests Rapid Diagnostic Tests Leukocytes Urinary Test PH Urinary Test FaStep Early Pregnancy Rapid Test Strip FaStep Early Pregnancy Rapid Test Cassette FaStep Early Pregnancy Rapid Test Midstream Rapid Diagnostic Tests Rapid Diagnostic Tests OvaMate Fertility Tracker

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2024-03-07
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2024-03-07
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2024-03-07
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2024-03-07
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2024-03-07
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2024-03-07
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2024-03-07
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2024-03-07
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2024-03-07
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-03-07
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2024-03-07
PVA	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3250	2024-03-07
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2025-11-30
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2025-02-16
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-02-16
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2025-02-16
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2025-02-16
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2025-02-16
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2025-02-16
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2025-02-16
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2025-02-16
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2025-02-16
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2025-02-16
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2025-02-16
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2025-02-16
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2025-02-16
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2024-03-07
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2024-03-07
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2024-03-07
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2024-03-07
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2024-03-07
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2024-03-07
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2024-03-07
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-03-07
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2024-03-07
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2024-03-07
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2024-03-07
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2024-03-07
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2024-03-07
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2024-03-07
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2024-03-07
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3610	2024-03-07
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2025-11-30
PVK	Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3910	2024-03-07
QYT	Over-The-Counter Covid-19 Antigen Test	Microbiology	Class 2	866.3984	2026-06-10
PVG	Test, Morphine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3640	2024-03-07
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-03-07
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3650	2024-03-07
PUZ	Test, Benzodiazepine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3170	2024-03-07
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2024-03-07
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2024-03-07
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2024-03-07
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2025-11-30
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2024-03-07
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2025-11-30
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2025-11-30
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2025-11-30
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2025-11-30
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2025-11-30
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2025-11-30
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2025-11-30
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2025-11-30
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2025-11-30
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2025-11-30
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2025-11-30
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2024-02-26
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2024-02-26
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-02-26
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2024-02-26
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2024-02-26
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2024-02-26
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2024-02-26
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2024-02-26
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2024-02-26
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2024-02-26
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2024-02-26
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2024-03-07
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2024-03-07
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2024-03-07
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2024-03-08
PUY	Test, Barbiturate, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3150	2024-03-07
PVF	Test, Methaqualone, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3630	2024-03-07
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2025-11-30
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2025-11-30
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-02-16
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3100	2024-03-07
MRS	Test System, Nicotine, Cotinine, Metabolites	Clinical Toxicology	Class 1	862.3220	2024-03-07
LHD	Device, Fertility Diagnostic, Proceptive	Unknown	Class U	N/A	2024-09-19

Official Correspondent

Allen Chen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Assure Tech LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01
Z-0029-2013	Alere San Diego, Inc.	2	Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030648160. Last updated year: 2026. Please use registration number 3030648160 when referencing this establishment in official correspondence.