FDA Registration
Active
🇮🇹 Italy
BIO-OPTICA MILANO SPA
Reg #: 3003313105
·
FEI: 3003313105
·
Expires 2026
Products
6
Proprietary Names
25
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- BIO-OPTICA MILANO SPA
- Registration Number
- 3003313105
- FEI Number
- 3003313105
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- VIA SAN FAUSTINO, 58
- City
- MILANO
- Country
- IT
Owner / Operator
- Firm Name
- BIO-OPTICA MILANO SPA
- Operator Number
- 9075939
- Address
- VIA SAN FAUSTINO, 58, --
- City
- MILANO
- State
- IT-NOTA
- Postal Code
- 20134
- Country
- IT
- Correspondent
- CINZIA - MARENGHI
US Agent
- Business Name
- STAT LAB
- Contact Name
- James Tentler
- Address
- 2090 COMMERCE DRIVE - Mc Kinney, Texas, 75069 - United States
- City
- Mc Kinney
- State
- TX
- ZIP
- 75069
- Country
- US
- [email protected]
- Phone
- 800 4223573 ext. 228
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stains, Chemical Solution | LED | Class 1 | Hematology | No | 2015-06-08 |
| Container, Embedding | KER | Class 1 | Pathology | No | 2015-06-05 |
| Device, Accessory, Cooling Plate For Tissue Embedding Station | MXT | Class 1 | Pathology | No | 2015-06-05 |
| Dispensers, Paraffin | IDW | Class 1 | Pathology | No | 2015-05-28 |
| Filters, Cell Collection, Tissue Processing | KET | Class 1 | Pathology | No | 2015-06-15 |
| Slide Stainer, Immersion Type | KIO | Class 1 | Pathology | No | 2005-08-02 |
Proprietary Names
Alkaline phosphatase 10 ml
ATPase 10 ml
NADH diaphorase 10 ml
Cytochrome C oxidase 10 ml
Phosphorylase 10 ml
Acid phosphatase 10 ml
Phosphofructokinase 10 ml
Succinic dehydrogenase 10 ml
Myoadenylate deaminase 10 ml
Non specific Esterase 10 ml
Bio Mold
BCP230 - Freezing plate
BCP170 - Cooling plate
BEC150 - Paraffin dispenser
Dual Cyto Cuvette
Biopsy pads
Endokit
Slide staining set 12 dishes 80 ml
Plastic rack 25 slide
Slide staining set 3 dishes
Slide staining set 12 dishes
PET dish- separated lid
PET dishes 80 ml
Slide staining set 3 dishes 80ml
PET dish with lid
Establishment Types
Manufacture Medical Device