FDA Registration
Active
🇫🇷 France
ABX PENTRA AMYLASE CP
Reg #: 3000148879
·
FEI: 3000148879
·
Expires 2025
Products
5
Proprietary Names
3
Establishment Types
2
Classifications
5
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
Regulatory Submissions
- 510(k) Number
- K070249
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 |
|---|---|---|---|---|---|
| Catalytic Methods, Amylase | JFJ | Class 2 | Clinical Chemistry | No | 2008-05-09 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2008-05-09 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2008-05-09 |
| Cresolphthalein Complexone, Calcium | CIC | Class 2 | Clinical Chemistry | No | 2008-05-09 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2008-05-09 |
Proprietary Names
ABX PENTRA AMYLASE CP
ABX PENTRA PHOSPHORUS CP
Yumizen C1200 Amylase
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device