FDA Registration
Active
🇺🇸 United States
Hangzhou AllTest Biotech Co., Ltd
Reg #: 3021186226
·
FEI: 3021186226
·
Expires 2025
Products
23
Proprietary Names
1
Establishment Types
1
Classifications
23
Registration Details
- Registration Name
- HOME HEALTH US INCORPORATED
- Registration Number
- 3021186226
- FEI Number
- 3021186226
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 7672 15th St E
- City
- Sarasota
- State
- FL
- ZIP
- 34243
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182738
Owner / Operator
- Firm Name
- Home Health US Inc
- Operator Number
- 10083434
- Address
- 7672 15th Street E
- City
- Sarasota
- State
- FL
- Postal Code
- 34243
- Country
- US
- Correspondent
- Luca J Hanson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Thin Layer Chromatography, Morphine | DNK | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2021-11-19 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Test, Morphine, Over The Counter | NGI | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2021-11-19 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2021-11-19 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2021-11-19 |
Proprietary Names
Hangzhou AllTest Biotech Co., Ltd
Establishment Types
Repack or Relabel Medical Device