Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030413233

FEI Number

3030413233

Entity Name

ABOUND Diagnostics, Inc

City/State/Country

San Diego, CA, US

Establishment Address

12396 World Trade Drive, Suite 216,, San Diego, CA 92128, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ABOUND Diagnostics, Inc. (Owner Number: 10090000)

Owner / Operator Contact Address

12396 World Trade Drive, suite 216,, San Diego, CA 92128, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250727

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2026-01-20
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2026-01-20
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2026-01-20
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2026-01-20
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2026-01-20
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2026-01-20
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2026-01-20
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2026-01-20
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2026-01-20
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2026-01-20
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2026-01-20
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2026-01-20
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2026-01-20
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2026-01-20
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2026-01-21
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2026-01-21
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2026-01-21
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2026-01-21
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2026-01-21
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2026-01-21
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2026-01-21
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2026-01-21
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2026-01-21
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2026-01-21
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2026-01-17
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2026-01-17
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2026-01-17
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2026-01-17
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2026-01-17
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2026-01-17
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2026-01-17
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2026-01-17
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2026-01-17
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2026-01-17
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2026-01-17
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2026-01-17
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2026-01-17
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2026-01-17
DNK	Thin Layer Chromatography, Morphine	Clinical Toxicology	Class 2	862.3640	2026-01-17
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2026-01-17
NGI	Test, Morphine, Over The Counter	Clinical Toxicology	Class 2	862.3640	2026-01-17
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2026-01-17
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2026-01-17
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2026-01-17
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2026-01-17
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2026-01-17
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2026-01-17
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2026-01-21
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2026-01-21
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2026-01-21
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2026-01-21
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2026-01-21
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2026-01-21
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2026-01-21
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2026-01-21
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2026-01-21
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2026-01-21
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2026-01-21
NGI	Test, Morphine, Over The Counter	Clinical Toxicology	Class 2	862.3640	2026-01-21
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2026-01-20
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2026-01-20
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2026-01-20
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2026-01-20
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2026-01-20
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2026-01-20
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2026-01-20
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2026-01-20
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2026-01-20
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2026-01-20
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2026-01-20

Official Correspondent

Lee Mariano

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABOUND Diagnostics, Inc.

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
K964108	Direct Access Diagnostics	FACT PLUS PREGNANCY TEST	1996-11-18
K945514	Princeton BioMeditech Corp.	LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG	1995-02-10
K150022	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream	2015-08-07
K043443	Guangzhou Wondfo Biotech Co., Ltd.	ONE STEP HCG URINE PREGNANCY TEST	2005-04-08
K173229	Guangzhou Wondfo Biotech Co., Ltd.	Preview Digital Pregnancy Test	2018-03-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-2787-2018	Guangzhou Wondfo Biotech Co., Ltd.	2	TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-2788-2018	Guangzhou Wondfo Biotech Co., Ltd.	2	TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-2789-2018	Guangzhou Wondfo Biotech Co., Ltd.	2	TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030413233. Last updated year: 2026. Please use registration number 3030413233 when referencing this establishment in official correspondence.