FDA Registration
Active
🇺🇸 United States
ACRO Multi-Drug Rapid Urine Test Cup (prescription & CLIA WAIVED)
Reg #: 3005360469
·
FEI: 3005670738
·
Expires 2025
Products
10
Proprietary Names
1
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- ACRO BIOTECH Inc.
- Registration Number
- 3005360469
- FEI Number
- 3005670738
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4650 Arrow Hwy Suite D6
- City
- Montclair
- State
- CA
- ZIP
- 91763
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241428
Owner / Operator
- Firm Name
- Acro Biotech Inc.
- Operator Number
- 10043465
- Address
- 4650 Arrow Hwy Suite D6
- City
- Montclair
- State
- CA
- Postal Code
- 91763
- Country
- US
- Correspondent
- Joseph Fan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2024-12-12 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2024-12-12 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2024-12-12 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2024-12-12 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2024-12-12 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2024-12-12 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2024-12-12 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2024-12-12 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2024-12-12 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2024-12-12 |
Proprietary Names
ACRO Multi-Drug Rapid Urine Test Cup (prescription & CLIA WAIVED)
Establishment Types
Repack or Relabel Medical Device