FDA Registration
Active
🇮🇹 Italy
BIOMERIEUX ITALIA-INDUSTRIAL DIV.
Reg #: 9615037
·
FEI: 3003261083
·
Expires 2026
Products
13
Proprietary Names
15
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- BIOMERIEUX ITALIA-INDUSTRIAL DIV.
- Registration Number
- 9615037
- FEI Number
- 3003261083
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- VIA DI CAMPIGLIANO 58
- City
- PONTE-A EMA, FLORENCE Firenze
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K141133
Owner / Operator
- Firm Name
- BIOMERIEUX SA
- Operator Number
- 8020790
- Address
- Chemin De L Orme
- City
- Marcy L Etoile
- State
- Rhone
- Postal Code
- 69280
- Country
- FR
US Agent
- Business Name
- BioMerieux SA
- Contact Name
- Nathan Hardesty
- Address
- 595 Anglum Rd, Bldg 1, 2nd Flr.
- City
- Hazelwood
- State
- MO
- ZIP
- 63042
- Country
- US
- [email protected]
- Phone
- 314 7318666
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | DAP | Class 2 | Hematology | No | 2015-07-20 |
| Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | LGD | Class 2 | Microbiology | No | 2015-07-20 |
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | Class 2 | Microbiology | No | 2015-07-20 |
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2015-07-20 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2015-07-20 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2015-07-20 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2015-07-20 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2015-07-20 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2015-07-20 |
| Reagent, Borrelia Serological Reagent | LSR | Class 2 | Microbiology | No | 2015-07-20 |
| Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates | QBN | Class 2 | Microbiology | No | 2022-03-16 |
| Igg, Antigen, Antiserum, Control | DEW | Class 2 | Immunology | No | 2007-12-27 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2004-07-07 |
Proprietary Names
VIDAS 3
VITEK MS Prime
VIDAS system
VITEK Immunodiagnostic Assay System
NucliSENS easyMAG Instrument
eMAG Tips 1000 microliters
eMAG Instrument
EASYMAG DISPOSABLE 384T
EMAG® V1.2 UPDATE INSTALLER DVD
EASYMAG RP5810 W7 DVD MASTER V2.1
EMAG® RP5810 W7 DVD MASTER V1.2
EMAG® Software V1.3
easyMAG® Software V2.1
EMAG® Software V1.4
MiniVIDAS Instrument
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)