FDA Registration
Active
🇫🇷 France
ABX Minotrol 16 (5300100303, 5300100306, 5300100312)
Reg #: 3000148879
·
FEI: 3000148879
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- HORIBA ABX SAS
- Registration Number
- 3000148879
- FEI Number
- 3000148879
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PARC EUROMEDECINE, RUE DU CADUCEE, BP 7290
- City
- MONTPELLIER Herault
- Country
- FR
Owner / Operator
- Firm Name
- HORIBA ABX SAS
- Operator Number
- 9036328
- Address
- PARC EUROMEDECINE, RUE DU CADUCEE, BP 7290
- City
- MONTPELLIER
- State
- FR-NOTA
- Postal Code
- 34184
- Country
- FR
US Agent
- Business Name
- HORIBA Instruments Incorporated
- Contact Name
- Will Cripps
- Address
- 5449 Research Drive, Canton, MI 48188
- City
- Canton
- State
- MI
- ZIP
- 48188
- Country
- US
- [email protected]
- Phone
- 800 4459853
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mixture, Hematology Quality Control | JPK | Class 2 | Hematology | No | 2024-05-30 |
Proprietary Names
ABX Minotrol 16 (5300100303, 5300100306, 5300100312)
BFTROL
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility