FDA Registration
Active
🇺🇸 United States
OMEGA LABORATORIES, INC.
Reg #: 3004847291
·
FEI: 3004847291
·
Expires 2026
Products
14
Proprietary Names
5
Establishment Types
3
Classifications
14
Registration Details
- Registration Name
- OMEGA LABORATORIES, INC.
- Registration Number
- 3004847291
- FEI Number
- 3004847291
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 400 N CLEVELAND AVE
- City
- MOGADORE
- State
- OH
- ZIP
- 44260
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101973
Owner / Operator
- Firm Name
- OMEGA LABORATORIES, INC.
- Operator Number
- 9074072
- Address
- 400 NORTH CLEVELAND, --
- City
- Mogadore
- State
- OH
- Postal Code
- 44260
- Country
- US
- Correspondent
- Bill - Corl
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | PVA | Class 2 | Clinical Toxicology | No | 2019-10-04 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2019-11-19 |
| Container, Specimen, Urine, Drugs Of Abuse, Over The Counter | MPQ | Class 1 | Pathology | No | 2005-11-16 |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | PVD | Class 2 | Clinical Toxicology | No | 2019-10-04 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2019-11-19 |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | PUX | Class 2 | Clinical Toxicology | No | 2019-10-04 |
| Test, Opiates, Employment And Insurance Testing, Exempt | PVH | Class 2 | Clinical Toxicology | No | 2019-10-04 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2019-11-19 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2019-11-19 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2019-11-19 |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | PUZ | Class 2 | Clinical Toxicology | No | 2019-10-04 |
| Devices, Breath Trapping, Alcohol | DJZ | Class 1 | Clinical Toxicology | No | 2019-10-04 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2019-11-19 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | PVJ | Class 2 | Clinical Toxicology | No | 2019-10-04 |
Proprietary Names
Druglizer LE5 Drug Tester System
Omega Laboratories Hair Drug Screening Assay
HAIR COLLECTION KIT
Alcolizer LE5 Alcohol Tester
Drugalizer LE5 Drug Tester System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility