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
Phone
240 5057880

Products

Device Name Product Code
Test, Methadone, Over The Counter PTG
Test, Propoxyphene, Over The Counter QBF
Test, Opiates, Over The Counter NGL
Enzyme Immunoassay, Phencyclidine LCM
Test, Tricyclic Antidepressants, Over The Counter QAW
Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
Test, Methamphetamine, Over The Counter NGG
Test, Cannabinoid, Over The Counter NFW
Test, Amphetamine, Over The Counter NFT
Test, Benzodiazepine, Over The Counter NFV
Test, Barbiturate, Over The Counter PTH

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