FDA Registration
Active
🇫🇷 France
ABX PENTRA CO2 RTU
Reg #: 3000148879
·
FEI: 3000148879
·
Expires 2025
Products
13
Proprietary Names
12
Establishment Types
1
Classifications
13
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
- K060205
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 |
|---|---|---|---|---|---|
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2006-10-05 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2006-10-05 |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | Class 2 | Clinical Chemistry | No | 2006-10-05 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2006-10-05 |
| Photometric Method, Iron (Non-Heme) | JIY | Class 1 | Clinical Chemistry | No | 2006-10-05 |
| Enzymatic, Carbon-Dioxide | KHS | Class 2 | Clinical Chemistry | No | 2006-10-05 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2006-10-05 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2006-10-05 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2006-10-05 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2006-10-05 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2006-10-05 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2006-10-05 |
| Cresolphthalein Complexone, Calcium | CIC | Class 2 | Clinical Chemistry | No | 2006-10-05 |
Proprietary Names
ABX PENTRA CO2 RTU
ABX PENTRA ALP CP
ABX PENTRA IRON CP
ABX PENTRA MAGNESIUM RTU
ABX PENTRA PHOSPHORUS CP
ABX PENTRA UREA CP
ABX PENTRA MULTICAL
ABX PENTRA URIC ACID CP
ABX PENTRA CO2 CONTROL
Yumizen C1200 Magnesium
Yumizen C1200 C02
ABX PENTRA CO2 CAL
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility