Congratulations！CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup Receive FDA 510(k) Approval
Date : 2025.09.12
We are thrilled to announce that our CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup (17-Panel Drug Test) have obtained FDA 510(K) clearance!
This innovative test is designed to detect 17 distinct drugs and metabolites in urine, including:
| Morphine (MOP) |
Propoxyphene (PPX) |
Nortriptyline (TCA) |
| Methamphetamine (MET) |
Amphetamine (AMP) |
Secobarbital (BAR) |
| Benzoylecgonine (COC) |
Phencyclidine (PCP) |
Methadone (MTD) |
| Marijuana (THC) |
Methadone metabolite (EDDP) |
6-Monoacetylmorphine (6-MAM) |
| Methylenedioxymethamphetamine (MDMA) |
Oxycodone (OXY) |
Fentanyl (FYL) |
| Buprenorphine (BUP) |
Oxazepam (BZO) |
|
Key advantages:1. FDA 510(k) cleared – regulatory assurance for professional and at-home use
2. 17-plex immunoassay – one urine sample, one step, seventeen drugs
3. Cup-format convenience – intuitive procedure, visual results in minutes
4. High reliability for screening – delivers consistent, reproducible results for both professional and home use
This achievement underscores our commitment to advancing public health and safety through cutting-edge diagnostic solutions.
Infectious Disease
Drugs of Abuse
Hormones
Tumor Markers
Cardiac Markers
Thrombus
Inflammation
Serum Proteins
Reproductive Health
Food Safety
Animal Disease
PCR Reagent
Others
