Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032147516

FEI Number

3032147516

Entity Name

ETERBIO, INC.

City/State/Country

Zhuhai Guangdong, CN

Establishment Address

Office 420, No. 1316, Caixia Street, Hengqin, Zhuhai City, Guangdong Province, China, Zhuhai Guangdong 519000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Eterbio, Inc. (Owner Number: 10091094)

Owner / Operator Contact Address

Office 420, No. 1316, Caixia Street, Hengqin, Zhuhai City, Guangdong Province, China, zhuhai, CN-GD 519000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) O-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) O-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) S-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) S-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) O-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) O-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) S-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) S-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) U-Catch Multi-Drug Test Dip Card(Colloidal Gold) U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold) U-Catch Multi-Drug Test Dip Card(Colloidal Gold) S-Trust PLUS Multi-Drug Test Cup(Colloidal Gold) U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) S-Trust XR Multi-Drug Test Cup(Colloidal Gold) U-Catch XR Multi-Drug Test Cup(Colloidal Gold) S-Trust SE Multi-Drug Test Cup(Colloidal Gold) U-Catch SE Multi-Drug Test Cup(Colloidal Gold) S-Trust Marijuana Test Dip Card 20(Colloidal Gold) S-Trust Marijuana Test Strip 40(Colloidal Gold) U-Catch Marijuana Test Strip 40(Colloidal Gold) S-Trust Marijuana Test Strip 20(Colloidal Gold) S-Trust Marijuana Test Dip Card 40(Colloidal Gold) U-Catch Marijuana Test Strip 20(Colloidal Gold) U-Catch Marijuana Test Dip Card 40(Colloidal Gold) U-Catch Marijuana Test Dip Card 20(Colloidal Gold) S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) S-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) O-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) S-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) O-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) ETERBIO Fentanyl/Norfentanyl Home Test S-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) O-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) S-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) O-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) S-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) S-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) O-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) O-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) U-Catch Multi-Drug Test Dip Card(Colloidal Gold) O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) U-Catch MAX Multi-Drug Test Cup(Colloidal Gold) U-Catch MAX Multi-Drug Test Cup Rx(Colloidal Gold) S-Trust MAX Multi-Drug Test Cup(Colloidal Gold) S-Trust MAX Multi-Drug Test Cup Rx(Colloidal Gold) O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) O-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) S-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) O-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) S-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) S-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) O-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) O-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) S-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) O-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) U-Catch Marijuana Multi-Level Drug Test Card(Colloidal Gold) S-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) O-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) S-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) U-Catch Multi-Drug Test Dip Card(Colloidal Gold) S-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) O-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) S-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) O-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3610	2024-07-29
PUZ	Test, Benzodiazepine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3170	2024-07-29
MRS	Test System, Nicotine, Cotinine, Metabolites	Clinical Toxicology	Class 1	862.3220	2024-07-29
DNN	Calibrators, Ethyl Alcohol	Clinical Toxicology	Class 2	862.3200	2026-03-17
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-06-30
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2024-06-30
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2024-06-30
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2024-06-30
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2024-06-30
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2024-06-30
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2024-06-30
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2024-06-30
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2024-06-30
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2024-06-30
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2024-06-30
NGI	Test, Morphine, Over The Counter	Clinical Toxicology	Class 2	862.3640	2024-06-30
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2024-07-29
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3650	2024-07-29
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2025-06-17
PUY	Test, Barbiturate, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3150	2024-07-29
PVG	Test, Morphine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3640	2024-07-29
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2024-07-29
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2024-07-29
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2024-07-29
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2024-07-29
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-07-29
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2024-07-29
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2024-07-29
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2024-07-29
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2024-07-29
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2024-07-29
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2024-07-29
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2024-07-29
PVB	Test, Codeine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3270	2024-07-29
PVA	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3250	2024-07-29
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3870	2024-07-29
PVF	Test, Methaqualone, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3630	2024-07-29

Official Correspondent

XIAOXIN LIN

US Agent Details

Shia Xia Email: jxia@lsi-consulting.org Phone: (301) 9167880

Related Public Records

Same Entity

Eterbio, 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
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

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3017904598	Guangzhou Decheng Biotechnology Co., Ltd.	Guangzhou Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032147516. Last updated year: 2026. Please use registration number 3032147516 when referencing this establishment in official correspondence.