FDA Registration
Active
🇬🇧 United Kingdom
MAST GROUP LTD.
Reg #: 8020667
·
FEI: 4247
·
Expires 2026
Products
10
Proprietary Names
14
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- MAST GROUP LTD.
- Registration Number
- 8020667
- FEI Number
- 4247
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- MAST HOUSE, DERBY RD.
- City
- BOOTLE, MERSEYSIDE Liverpool
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K103538
Owner / Operator
- Firm Name
- MAST GROUP LTD.
- Operator Number
- 8020667
- Address
- MAST HOUSE, DERBY RD
- City
- BOOTLE
- State
- Liverpool
- Postal Code
- L20 1EA
- Country
- GB
US Agent
- Business Name
- Hardy Diagnostics
- Contact Name
- Ashleigh Rickey
- Address
- 1430 W Mccoy Ln
- City
- Santa Maria
- State
- CA
- ZIP
- 93455
- Country
- US
- [email protected]
- Phone
- 800 2662222 ext. 7045
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Susceptibility Test Discs, Antimicrobial | JTN | Class 2 | Microbiology | No | 2014-09-15 |
| Antisera, All Types, Escherichia Coli | GNA | Class 1 | Microbiology | No | 2006-09-07 |
| System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies | MYI | Class 2 | Microbiology | No | 2006-11-28 |
| Antisera, All Types, H. Influenza | GRP | Class 2 | Microbiology | No | 2006-09-07 |
| Antisera, All Groups, Salmonella Spp. | GRM | Class 2 | Microbiology | No | 2006-09-07 |
| Kit, Screening, Urine | JXA | Class 1 | Microbiology | No | 2006-09-07 |
| Antiserum, Vibrio Cholerae, All Varieties | GSQ | Class 2 | Microbiology | No | 2006-09-07 |
| Discs, Strips And Reagents, Microorganism Differentiation | JTO | Class 1 | Microbiology | No | 1999-01-06 |
| Plasma, Coagulase, Human, Horse And Rabbit | JTL | Class 1 | Microbiology | No | 2022-09-12 |
| Antisera, All Types, Shigella Spp. | GNB | Class 2 | Microbiology | No | 2006-09-07 |
Proprietary Names
Hardy Disks
Lefamulin
MastAssure
Hardy Discs
HardyDisk Aztreonam/Avibactam
Plazomicin
Staph
HardyDisk AST Cefiderocol
HardyDisk Gepotidacin
Imipenem/Relebactam
Urine screen
Meropenem/Vaborbactam
Eravacycline
CoaguStaph
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device