FDA Registration
Active
🇺🇸 United States
MD DrugScreen Test
Reg #: 3009212837
·
FEI: 3009212837
·
Expires 2025
Products
9
Proprietary Names
1
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- MEDICAL DISPOSABLES CORP
- Registration Number
- 3009212837
- FEI Number
- 3009212837
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6831 Edgewater Commerce Pkwy, Ste 1101
- City
- Orlando
- State
- FL
- ZIP
- 32810
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153597
Owner / Operator
- Firm Name
- Medical Disposables Corp
- Operator Number
- 10055555
- Address
- 6831 Edgewater Commerce Pkwy, Ste 1101
- City
- Orlando
- State
- FL
- Postal Code
- 32810
- Country
- US
- Correspondent
- Ralph Hernandez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2019-09-05 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2019-09-05 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2019-09-05 |
Proprietary Names
MD DrugScreen Test
Establishment Types
Repack or Relabel Medical Device
Manufacture Device in the United States for Export Only
Complaint File Establishment per 21 CFR 820.198