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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2020-12-24 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2020-12-24 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2020-12-24 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2020-12-24 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2020-12-24 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2020-12-24 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2020-12-24 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2020-12-24 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2020-12-24 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2020-12-24 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2020-12-24 |
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