Eterbio, Inc.
Manufacturer and brand owner in Zhuhai, Guangdong, China. 29 device types, 8 products catalogued, 1 clearance.
Eterbio, Inc. is a manufacturer holding a current FDA establishment registration. The registration covers Calibrators, Ethyl Alcohol, Enzyme Immunoassay, Opiates and 27 other device types. 8 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2024.
29device types registered with the FDA
8products catalogued under its own name
1510(k) clearance
Registration
| Registered name | ETERBIO, INC. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3032147516 |
| FEI number | 3032147516 |
| DUNS | 638595825 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 該公司类别属于私人股份有限公司 |
|---|---|
| Source | Hong Kong company register lookup |
Location
| City | Zhuhai |
|---|---|
| Province | Guangdong |
| Address | Office 420, No. 1316, Caixia Street, Hengqin, Zhuhai City, Guangdong Province, China |
| Postal code | 519000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Calibrators, Ethyl Alcohol | Class 2 | U-Catch Multi-Drug Test Dip Card(Colloidal Gold) | 2026 | 1 |
| Enzyme Immunoassay, Cannabinoids | Class 2 | U-Catch Marijuana Test Strip 20(Colloidal Gold), S-Trust Marijuana Test Dip Card 40(Colloidal Gold), S-Trust Marijuana Test Strip 40(Colloidal Gold), S-Trust Marijuana Test Dip Card 20(Colloidal Gold), U-Catch Marijuana Test Strip 40(Colloidal Gold), S-Trust Marijuana Test Strip 20(Colloidal Gold) and 2 more | 2024 | 18 |
| Enzyme Immunoassay, Opiates | Class 2 | S-Trust MAX Multi-Drug Test Cup(Colloidal Gold), U-Catch MAX Multi-Drug Test Cup Rx(Colloidal Gold), U-Catch MAX Multi-Drug Test Cup(Colloidal Gold), S-Trust MAX Multi-Drug Test Cup Rx(Colloidal Gold) | 2024 | 17 |
| Test System, Nicotine, Cotinine, Metabolites | Class 1 | U-Catch Multi-Drug Test Dip Card(Colloidal Gold), U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold) | 2024 | 11 |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | Class 2 | 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), O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) | 2024 | 11 |
| Test, Amphetamine, Over The Counter | Class 2 | U-Catch XR Multi-Drug Test Cup(Colloidal Gold), U-Catch SE Multi-Drug Test Cup(Colloidal Gold), S-Trust SE Multi-Drug Test Cup(Colloidal Gold), S-Trust XR Multi-Drug Test Cup(Colloidal Gold), U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold), S-Trust PLUS Multi-Drug Test Cup(Colloidal Gold) and 4 more | 2024 | 16 |
| Test, Barbiturate, Employment And Insurance Testing, Exempt | Class 2 | S-Trust SE 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 Plus 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) | 2024 | 11 |
| Test, Barbiturate, Over The Counter | Class 2 | U-Catch XR Multi-Drug Test Cup(Colloidal Gold), U-Catch SE Multi-Drug Test Cup(Colloidal Gold), S-Trust SE Multi-Drug Test Cup(Colloidal Gold), S-Trust XR Multi-Drug Test Cup(Colloidal Gold), U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold), S-Trust PLUS Multi-Drug Test Cup(Colloidal Gold) and 4 more | 2024 | 16 |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | Class 2 | O-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold), S-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold), S-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold), S-Trust SE 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) | 2024 | 11 |
| Test, Benzodiazepine, Over The Counter | Class 2 | U-Catch XR Multi-Drug Test Cup(Colloidal Gold), U-Catch SE Multi-Drug Test Cup(Colloidal Gold), S-Trust SE Multi-Drug Test Cup(Colloidal Gold), S-Trust XR Multi-Drug Test Cup(Colloidal Gold), U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold), S-Trust PLUS Multi-Drug Test Cup(Colloidal Gold) and 4 more | 2024 | 16 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | Class 2 | U-Catch Multi-Drug Test Dip Card(Colloidal Gold), O-Trust SE 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), U-Catch Marijuana Multi-Level Drug Test Card(Colloidal Gold), O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) and 2 more | 2024 | 12 |
| Test, Cannabinoid, Over The Counter | Class 2 | U-Catch XR Multi-Drug Test Cup(Colloidal Gold), U-Catch SE Multi-Drug Test Cup(Colloidal Gold), S-Trust SE Multi-Drug Test Cup(Colloidal Gold), S-Trust XR Multi-Drug Test Cup(Colloidal Gold), U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold), S-Trust PLUS Multi-Drug Test Cup(Colloidal Gold) and 8 more | 2024 | 16 |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | Class 2 | O-Trust Plus Oral Fluid Multi-Drug Test Cup(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 SE 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) | 2024 | 12 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | Class 2 | U-Catch XR Multi-Drug Test Cup(Colloidal Gold), U-Catch SE Multi-Drug Test Cup(Colloidal Gold), S-Trust SE Multi-Drug Test Cup(Colloidal Gold), S-Trust XR Multi-Drug Test Cup(Colloidal Gold), U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold), S-Trust PLUS Multi-Drug Test Cup(Colloidal Gold) and 4 more | 2024 | 16 |
| Test, Codeine, Employment And Insurance Testing, Exempt | Class 2 | O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold), S-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 SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold), O-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) | 2024 | 4 |
| Test, Methadone, Employment And Insurance Testing, Exempt | Class 2 | S-Trust Plus 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 SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) | 2024 | 11 |
| Test, Methadone, Over The Counter | Class 2 | U-Catch XR Multi-Drug Test Cup(Colloidal Gold), U-Catch SE Multi-Drug Test Cup(Colloidal Gold), S-Trust SE Multi-Drug Test Cup(Colloidal Gold), S-Trust XR Multi-Drug Test Cup(Colloidal Gold), U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold), S-Trust PLUS Multi-Drug Test Cup(Colloidal Gold) and 4 more | 2024 | 17 |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | Class 2 | O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold), O-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 SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold), S-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) | 2024 | 13 |
| Test, Methamphetamine, Over The Counter | Class 2 | U-Catch XR Multi-Drug Test Cup(Colloidal Gold), U-Catch SE Multi-Drug Test Cup(Colloidal Gold), S-Trust SE Multi-Drug Test Cup(Colloidal Gold), S-Trust XR Multi-Drug Test Cup(Colloidal Gold), U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold), S-Trust PLUS Multi-Drug Test Cup(Colloidal Gold) and 4 more | 2024 | 16 |
| Test, Methaqualone, Employment And Insurance Testing, Exempt | Class 2 | S-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), O-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold), S-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold) | 2024 | 6 |
| Test, Morphine, Employment And Insurance Testing, Exempt | Class 2 | O-Trust Plus Oral Fluid Multi-Drug Test Cup(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 Oral Fluid Multi-Drug Test Card(Colloidal Gold), S-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold), U-Catch Multi-Drug Test Dip Card(Colloidal Gold) and 1 more | 2024 | 8 |
| Test, Morphine, Over The Counter | Class 2 | U-Catch XR Multi-Drug Test Cup(Colloidal Gold), U-Catch SE Multi-Drug Test Cup(Colloidal Gold), S-Trust SE Multi-Drug Test Cup(Colloidal Gold), S-Trust XR Multi-Drug Test Cup(Colloidal Gold), U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold), S-Trust PLUS Multi-Drug Test Cup(Colloidal Gold) | 2024 | 4 |
| Test, Opiates, Employment And Insurance Testing, Exempt | Class 2 | O-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold), O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold), O-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold), S-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold), S-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold), S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) | 2024 | 12 |
| Test, Opiates, Over The Counter | Class 2 | U-Catch XR Multi-Drug Test Cup(Colloidal Gold), U-Catch SE Multi-Drug Test Cup(Colloidal Gold), S-Trust SE Multi-Drug Test Cup(Colloidal Gold), S-Trust XR Multi-Drug Test Cup(Colloidal Gold), U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold), S-Trust PLUS Multi-Drug Test Cup(Colloidal Gold) and 8 more | 2024 | 18 |
| Test, Phencyclidine (Pcp), Over The Counter | Class U | U-Catch XR Multi-Drug Test Cup(Colloidal Gold), U-Catch SE Multi-Drug Test Cup(Colloidal Gold), S-Trust SE Multi-Drug Test Cup(Colloidal Gold), S-Trust XR Multi-Drug Test Cup(Colloidal Gold), U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold), S-Trust PLUS Multi-Drug Test Cup(Colloidal Gold) and 4 more | 2024 | 12 |
| Test, Propoxyphene, Employment And Insurance Testing, Exempt | Class 2 | O-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), S-Trust Plus Oral Fluid Multi-Drug Test Cup(Colloidal Gold), S-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold), O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) | 2024 | 7 |
| Test, Propoxyphene, Over The Counter | Class 2 | U-Catch XR Multi-Drug Test Cup(Colloidal Gold), U-Catch SE Multi-Drug Test Cup(Colloidal Gold), S-Trust SE Multi-Drug Test Cup(Colloidal Gold), S-Trust XR Multi-Drug Test Cup(Colloidal Gold), U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold), S-Trust PLUS Multi-Drug Test Cup(Colloidal Gold) and 4 more | 2024 | 16 |
| Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt | Class 2 | O-Trust Plus Oral Fluid Multi-Drug Test Cup(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), S-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold), O-Trust Oral Fluid Multi-Drug Test Card(Colloidal Gold) | 2024 | 7 |
| Test, Tricyclic Antidepressants, Over The Counter | Class 2 | U-Catch XR Multi-Drug Test Cup(Colloidal Gold), U-Catch SE Multi-Drug Test Cup(Colloidal Gold), S-Trust SE Multi-Drug Test Cup(Colloidal Gold), S-Trust XR Multi-Drug Test Cup(Colloidal Gold), U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold), S-Trust PLUS Multi-Drug Test Cup(Colloidal Gold) and 4 more | 2024 | 16 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold) | MRS | 2 |
| U-Catch Plus Multi-Drug Test Cup(Colloidal Gold) | NGL | 1 |
| U-Catch Plus Multi-Drug Test Cup(Colloidal Gold) | NGI | 1 |
| Eterbio Fentanyl/Norfentanyl Home Test | NGL | 1 |
| S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold) | PUX | 1 |
| U-Catch Marijuana Multi-Level Drug Test Card(Colloidal Gold) | PVJ | 1 |
| U-Catch XR Multi-Drug Test Cup(Colloidal Gold) | NGL | 1 |
| U-Catch Plus Multi-Drug Test Cup(Colloidal Gold) | NFV | 1 |
Clearances
1 clearance names Eterbio, Inc. as applicant. 5 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K243064 | 2024-11-20 | NGL | Traditional | This company |
| K230238 | 2023-03-31 | DJG | Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. |
| K193480 | 2020-01-31 | NGL | Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. |
| K192515 | 2019-10-11 | LDJ | Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. |
| K192301 | 2019-09-20 | NFW | Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. |
| K182530 | 2018-11-09 | NFT | Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2023 |
|---|---|
| Main products | in vitro diagnostic reagents, drug abuse screening, infectious disease testing, immunofluorescence analyzers |
| Certifications | FDA 510K, CLIA Waived |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.