FDA Registration
Active
🇺🇸 United States
IMMUNOSTICS, INC.
Reg #: 2244821
·
FEI: 2244821
·
Expires 2025
Products
9
Proprietary Names
0
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- IMMUNOSTICS, INC.
- Registration Number
- 2244821
- FEI Number
- 2244821
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 38 Industrial Way E Ste 1
- City
- Eatontown
- State
- NJ
- ZIP
- 07724
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153597
Owner / Operator
- Firm Name
- IMMUNOSTICS, INC.
- Operator Number
- 2244821
- Address
- 38 INDUSTRIAL WAY EAST, SUITE 1, --
- City
- Eatontown
- State
- NJ
- Postal Code
- 07724
- Country
- US
- Correspondent
- Young Mi Kim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2017-03-30 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2017-03-30 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2017-03-30 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2017-03-30 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2017-03-30 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2017-03-30 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2017-03-30 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2017-03-30 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2017-03-30 |
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198