FDA Registration
Active
🇨🇳 China
ETERBIO, INC.
Reg #: 3032147516
·
FEI: 3032147516
·
Expires 2026
Products
29
Proprietary Names
33
Establishment Types
2
Classifications
29
Registration Details
- Registration Name
- ETERBIO, INC.
- Registration Number
- 3032147516
- FEI Number
- 3032147516
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Office 420, No. 1316, Caixia Street, Hengqin, Zhuhai City, Guangdong Province, China
- City
- Zhuhai Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K193480
Owner / Operator
- Firm Name
- Eterbio, Inc.
- Operator Number
- 10091094
- Address
- Office 420, No. 1316, Caixia Street, Hengqin, Zhuhai City, Guangdong Province, China
- City
- zhuhai
- State
- Guangdong
- Postal Code
- 519000
- Country
- CN
- Correspondent
- XIAOXIN LIN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | PVD | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | PUZ | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test System, Nicotine, Cotinine, Metabolites | MRS | Class 1 | Clinical Toxicology | No | 2024-07-29 |
| Calibrators, Ethyl Alcohol | DNN | Class 2 | Clinical Toxicology | No | 2026-03-17 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2024-06-30 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2024-06-30 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2024-06-30 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2024-06-30 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2024-06-30 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2024-06-30 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2024-06-30 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2024-06-30 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2024-06-30 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2024-06-30 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2024-06-30 |
| Test, Morphine, Over The Counter | NGI | Class 2 | Clinical Toxicology | No | 2024-06-30 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Opiates, Employment And Insurance Testing, Exempt | PVH | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Barbiturate, Employment And Insurance Testing, Exempt | PUY | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Morphine, Employment And Insurance Testing, Exempt | PVG | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Codeine, Employment And Insurance Testing, Exempt | PVB | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | PVA | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | PVJ | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Methaqualone, Employment And Insurance Testing, Exempt | PVF | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Propoxyphene, Employment And Insurance Testing, Exempt | PVI | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt | PVK | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | PUX | Class 2 | Clinical Toxicology | No | 2024-07-29 |
| Test, Methadone, Employment And Insurance Testing, Exempt | PVE | Class 2 | Clinical Toxicology | No | 2024-07-29 |
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)
U-Catch Multi-Drug Test Dip Card(Colloidal Gold)
U-Catch Cotinine (COT) 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)
ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold)
ETERBIO Fentanyl/Norfentanyl Home Test
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)
U-Catch Marijuana Multi-Level Drug Test Card(Colloidal Gold)
U-Catch Marijuana Test Strip(Colloidal Gold)
S-Trust Marijuana Test Dip Card(Colloidal Gold)
S-Trust Marijuana Test Strip(Colloidal Gold)
U-Catch Marijuana Test Dip Card(Colloidal Gold)
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device