FDA Registration
Active
🇫🇷 France
Yumizen C Level 2 HbA1c Control
Reg #: 3000148879
·
FEI: 3000148879
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
1
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 |
|---|---|---|---|---|---|
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2020-05-13 |
Proprietary Names
Yumizen C Level 2 HbA1c Control
Yumizen C1200 N multi Control
Yumizen C1200 Level 2 Protein Control
Yumizen C1200 P multi Control
ABX Pentra P MultiControl
Yumizen C Level 1 HbA1c Control
Yumizen C1200 U/CSF L1 Micro Alb Control
Yumizen C1200 Level 1 Protein Control
ABX Pentra N MultiControl
Yumizen C Urine Level 1 Control
Yumizen C1200 Level 2 CRPhs Control
Yumizen C Urine Level 2 Control
Yumizen C1200 Level 1 CRPhs Control
Yumizen C1200 U/CSF L2 Micro Alb Control
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility