FDA Registration
Active
🇺🇸 United States
LifeScale Gram Negative (LSGN) kit
Reg #: 2022807
·
FEI: 2022807
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- HARDY DIAGNOSTICS
- Registration Number
- 2022807
- FEI Number
- 2022807
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1430 WEST MCCOY LN.
- City
- Orcutt
- State
- CA
- ZIP
- 93455
- Country
- US
Regulatory Submissions
- 510(k) Number
- K211815
Owner / Operator
- Firm Name
- HARDY DIAGNOSTICS
- Operator Number
- 2022807
- Address
- 1430 West McCoy Lane, --
- City
- Santa Maria
- State
- CA
- Postal Code
- 93455
- Country
- US
- Correspondent
- JAY - HARDY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | LON | Class 2 | Microbiology | No | 2024-11-06 |
| Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples | SAN | Class 2 | Microbiology | No | 2024-11-06 |
Proprietary Names
LifeScale Gram Negative (LSGN) kit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)