FDA Registration
Active
🇺🇸 United States
TRUE LEVEL Instant Drug Test
Reg #: 3013679502
·
FEI: 3013679502
·
Expires 2025
Products
3
Proprietary Names
5
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- PREGMATE LLC
- Registration Number
- 3013679502
- FEI Number
- 3013679502
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3804 N 29th Ave
- City
- Hollywood
- State
- FL
- ZIP
- 33020
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153646
Owner / Operator
- Firm Name
- PREGMATE LLC
- Operator Number
- 10055200
- Address
- 2268 ANCHOR CT
- City
- Fort Lauderdale
- State
- FL
- Postal Code
- 33312
- Country
- US
- Correspondent
- VIKTAR MAROZAU
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2017-07-14 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2017-07-14 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2017-07-14 |
Proprietary Names
TRUE LEVEL Instant Drug Test
TRUE LEVEL Drug Test
TRUE LEVEL Drug Screen Test Kit Dip Card
TRUE LEVEL Instant Drug Test At Home Urine Drug Test Kit
TRUE LEVEL Multi-Drug Testing Kit
Establishment Types
Repack or Relabel Medical Device