FDA Registration
Active
🇨🇳 China
INDICAID Multi-Drug Urine Test Cup
Reg #: 3004635103
·
FEI: 3004635103
·
Expires 2025
Products
11
Proprietary Names
56
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- GUANGZHOU WONDFO BIOTECH CO., LTD.
- Registration Number
- 3004635103
- FEI Number
- 3004635103
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.8 Lizhishan Road, Science City, Huangpu District
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K182701
Owner / Operator
- Firm Name
- GUANGZHOU WONDFO BIOTECH CO., LTD.
- Operator Number
- 9064561
- Address
- No.8 lizhishan Road, Science City, Huangpu District, 510663
- City
- GUANGZHOU
- State
- Guangdong
- Postal Code
- 510663
- Country
- CN
- Correspondent
- Jihua - Wang
US Agent
- Business Name
- LSI International Inc.
- Contact Name
- Joe Shia
- Address
- 504 East Diamond Ave., Suite I
- City
- Gaithersburg
- State
- MD
- ZIP
- 20877
- Country
- US
- [email protected]
- Phone
- 240 5057880
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2018-12-17 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2018-12-17 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2018-12-17 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2018-12-17 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2018-12-17 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2018-12-17 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2018-12-17 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2018-12-17 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2018-12-17 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2018-12-17 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2018-12-17 |
Proprietary Names
INDICAID Multi-Drug Urine Test Cup
CheckNow Multi - Drug Urine Test Cup
Areta Multi-Drug Test Cup
Mercedes Scientific, BluRapids Multi-Drug Test Cup
Alere Toxicology Services, Alere T-Cup Compact Multi-Drug Urine Test Cup
Alere Toxicology Services, UScreen Drug Test Cup
Guangzhou Wondfo Biotech Co., Wondfo VacuLid Multi-Drug Urine Test Cup
Wondfo USA Co., Ltd. Q-Cup Multi-Drug Urine Test Cup
Easy@Home Drug Test Cup, ECDOA-6125B
Magenta Multi-Drug Urine Test Cup, Magenta Multi-Drug Urine Test Compact Cup
Areta Multi-Drug Test Cup, ACDOA-264
RST Home Drug Test Kit Cup (Urine)
T-Cup Multi-Drug Urine Test Cup
Mintegrity® Multi-Drug Urine Test Cup
Areta Multi-Drug Test Cup, ACDOA-1144
Micro Distributing II, Ltd, STAT Cup One Step Drug Test
Prime Screen® Multi-Drug Urine Test Cup
Medline Drug Test Cup
SAFElife C-Cup Multi-Drug Urine Test Cup
easy@Home Drug Test Cup, ECDOA3-6125B
UA Multi-Drug Urine Test Cup
iSCREEN URINE TEST DX DRUG SCREEN COMPACT ROUND CUP
iSCREEN URINE TEST DX DRUG SCREEN ROUND CUP
T-Cup® Multi-Drug Urine Test Cup
Wondfo T-Cup Multi-Drug Urine Test Cup
BluRapids® MULTI-DRUG TEST CUP
Easy@Home Multi-Drug Test Cup,ECDOA-1144A3
easy@Home® Drug Test Cup
Clarity Multi-Drug Urine Test Cup (Urine)
Areta Multi-Drug Test Cup, ACDOA-6125B
iSCREEN Urine Test Dx Drug Screen Round Cup
Easy Healthcare Corporation, Easy@Home Drug Test Cup
iSCREEN URINE TEST DX DRUG SCREEN SQUARE CUP
QTEST Multi-Drug Urine Test Compact Cup
IDT Multi Drug Urine Test Compact Cup
SAFElife S-Cup Multi-Drug Urine Test Cup
Guangzhou Wondfo Co., Ltd., Wondfo Multi-Drug Urine Rx Test Cup
iSCREEN Urine Test Drug Screen Square Cup
Easy@Home Drug Test Cup, ECDOA-1144A3
Wondfo USA Co., Ltd. T-Cup Flat Multi-Drug Urine Test Cup
Easy@Home Drug Test Cup, ECDOA-7124
T-Cup Compact Multi-Drug Urine Test Cup, CDOA-6125
Multi-Drug Test Cup
STATCUP® One Step Drug Test
Drug Test Cup
Easy@Home Drug Test Cup, ECDOA-254
2SAN Home Drug Test Cup
Areta Multi-Drug Test Cup, ACDOA-754
SAFElife F-Cup Multi-Drug Urine Test Cup
iSCREEN URINE TEST DRUG SCREEN SQUARE CUP
STATCUP® II One Step Drug Test
SAFElife T-Cup Multi-Drug Urine Test Cup
PRIME SCREEN® Multi-Drug Urine Test Cup
T-Cup® Compact Multi-Drug Urine Test Cup
2SAN Home Drug Test Kit
IDT Multi Drug Urine Test Cup
Establishment Types
Manufacture Medical Device