FDA Registration Active 🇺🇸 United States

Wondfo T-Dip Multi-Drug Urine Test Panel

Reg #: 3007606081 · FEI: 3007606081 · Expires 2025
Products
11
Proprietary Names
76
Establishment Types
1
Classifications
11

Registration Details

Registration Name
WONDFO USA CO., LTD.
Registration Number
3007606081
FEI Number
3007606081
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
890 Remington Blvd
City
Bolingbrook
State
IL
ZIP
60440
Country
US

Regulatory Submissions

510(k) Number
K202567

Owner / Operator

Firm Name
Wondfo USA Co., Ltd.
Operator Number
10028951
Address
890 REMINGTON BLVD
City
Bolingbrook
State
IL
Postal Code
60440
Country
US
Correspondent
Kunyuan Mao

Products

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

Proprietary Names

Wondfo T-Dip Multi-Drug Urine Test Panel Easy Healthcare Corporation, Easy@Home Multi-Drug Screen Test Wondfo T-Dip Multi-Drug Urine Test Panel Rx SAFElife™ T-Dip Amphetamine (AMP) Urine Test Panel SAFElife™ T-Dip Multi-Drug Urine Test Panel Rx SAFElife™ T-Dip Secobarbital (BAR) Urine Test Panel SAFElife™ T-Dip Amphetamine (AMP) Urine Test Panel Rx iSCREEN™ Urine Test Dx Drug Screen Dip Card (Buprenorphine (BUP)) SAFElife™ T-Dip Methadone (MTD) Urine Test Panel Rx Easy@Home® Multi-Drug Screen Test, EDOAP-7104 SAFElife™ T-Dip Methamphetamine (MET500/mAMP500) Urine Test Panel Rx Easy@Home® Multi-Drug Screen Test, EDOAP-6125B SAFElife™ T-Dip Buprenorphine (BUP) Urine Test Panel Rx ONCORE DETOX Single Drug Dip Card (AMP) iSCREEN™ Urine Test Dx Drug Screen Dip Card (Methylenedioxymethamphetamine (MDMA)) SAFElife™ T-Dip Buprenorphine (BUP) Urine Test Panel SAFElife™ T-Dip Amphetamine (AMP500) Urine Test Panel PRIME SCREEN® Multi-Panel Urine Test ONCORE DETOX Single Drug Dip Card (THC) ONCORE DETOX Single Drug Dip Card (MET/mAMP) Easy@Home® Multi-Drug Screen Test, EDOAP-754 SAFElife™ T-Dip Methamphetamine (MET/mAMP) Urine Test Panel Rx Easy@Home® Multi-Drug Screen Test, EDOAP-654 SAFElife™ T-Dip Cocaine (COC150) Urine Test Panel PRIME SCREEN® Single Panel Urine Test Cannabinoids (THC) SAFElife™ T-Dip Phencyclidine (PCP) Urine Test Panel ONCORE DETOX Single Drug Dip Card (COC) Easy@Home® Multi-Drug Screen Test, EDOAP-3104 SAFElife™ T-Dip Cocaine (COC) Urine Test Panel SAFElife™ T-Dip Methadone (MTD) Urine Test Panel Easy@Home® Multi-Drug Screen Test, EDOAP-254 SAFElife™ T-Dip Opiate (OPI) Urine Test Panel Rx SAFElife™ T-Dip Methylenedioxymethamphetamine (MDMA) Urine Test Panel Easy@Home® Multi-Drug Screen Test, EDOAP-144 SAFElife™ T-Dip Multi-Drug Urine Test Panel SAFElife™ T-Dip Methamphetamine (MET/mAMP) Urine Test Panel PRIME SCREEN® Single Panel Urine Test ONCORE DETOX Single Drug Dip Card (OPI) Multi-Drug Urine Test Panel SAFElife™ T-Dip Oxycodone (OXY) Urine Test Panel Rx Easy@Home® Single Drug Screen Test SAFElife™ T-Dip Morphine (MOP) Urine Test Panel SAFElife™ T-Dip Oxycodone (OXY) Urine Test Panel iSCREEN™ Urine Test Dx Drug Screen Dip Card (Morphine (MOP)) SAFElife™ T-Dip Oxazepam (BZO) Urine Test Panel SAFElife™ T-Dip Methamphetamine (MET500/mAMP500) Urine Test Panel SAFElife™ T-Dip Propoxyphene (PPX) Urine Test Panel Rx Easy@Home® Multi-Drug Screen Test, EDOAP-1124 SAFElife™ T-Dip Propoxyphene (PPX) Urine Test Panel Easy@Home® Multi-Drug Screen Test, EDOAP-264 SAFElife™ T-Dip Phencyclidine (PCP) Urine Test Panel Rx STATDIP® One Step Drug Test iSCREEN™ Urine Test Dx Drug Screen Dip Card (Methamphetamine (MET)) SAFElife™ T-Dip Cocaine (COC150) Urine Test Panel Rx Easy@Home Multi-Drug Screen Test, EDOAP-4104 Single Drug Screen Test Single Drug Urine Test Panel SAFElife™ T-Dip Cannabinoids (THC) Urine Test Panel SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel Rx iSCREEN™ URINE TEST DX DRUG SCREEN DIP CARD SAFElife™ T-Dip Secobarbital (BAR) Urine Test Panel Rx SAFElife™ T-Dip Morphine (MOP) Urine Test Panel Rx SAFElife™ T-Dip Methylenedioxymethamphetamine (MDMA) Urine Test Panel Rx SAFElife™ T-Dip Cannabinoids (THC) Urine Test Panel Rx SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel PRIME SCREEN® Single Panel Urine Test Cocaine (COC) iSCREEN™ Urine Test Dx Drug Screen Dip Card (Oxycodone (OXY)) SAFElife™ T-Dip Oxazepam (BZO) Urine Test Panel Rx SAFElife™ T-Dip Cocaine (COC) Urine Test Panel Rx SAFElife™ T-Dip Amphetamine (AMP500) Urine Test Panel Rx SAFElife™ T-Dip Opiate (OPI) Urine Test Panel SAFElife™ T-Dip Single Drug Urine Test Panel ONCORE DETOX Multi-Drug Dip Card Multi-Drug Screen Test Easy@Home Multi-Drug Screen Test, EDOAP-7125 PRIME SCREEN® Single Panel Urine Test Oxazepam (BZO)

Establishment Types

Complaint File Establishment per 21 CFR 820.198