FDA Registration
Active
🇮🇹 Italy
DIAPATH S.P.A.
Reg #: 3010692993
·
FEI: 3010692993
·
Expires 2026
Products
16
Proprietary Names
46
Establishment Types
2
Classifications
16
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Registration Details
- Registration Name
- DIAPATH S.P.A.
- Registration Number
- 3010692993
- FEI Number
- 3010692993
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- via savoldini 71
- City
- Martinengo Bergamo
- Country
- IT
Owner / Operator
- Firm Name
- Diapath S.p.A.
- Operator Number
- 10049807
- Address
- via savoldini 71
- City
- Martinengo
- State
- Bergamo
- Postal Code
- 24057
- Country
- IT
- Correspondent
- Chiara Bergamini
US Agent
- Business Name
- StatLab Medical Products
- Contact Name
- Antonio Lizarraga
- Address
- 2090 Commerce Dr
- City
- Mckinney
- State
- TX
- ZIP
- 75069
- Country
- US
- [email protected]
- Phone
- 800 4423573
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filters, Cell Collection, Tissue Processing | KET | Class 1 | Pathology | No | 2025-03-11 |
| Microtome, Accessories | IDL | Class 1 | Pathology | No | 2018-07-31 |
| Device, Accessory, Cooling Plate For Tissue Embedding Station | MXT | Class 1 | Pathology | No | 2015-08-04 |
| Microtome, Rotary | IDO | Class 1 | Pathology | No | 2015-08-03 |
| Cassettes, Tissue | IDZ | Class 1 | Pathology | No | 2021-02-25 |
| Processor, Tissue, Automated | IEO | Class 1 | Pathology | No | 2015-08-04 |
| Fixative, Alcohol Containing | LDZ | Class 1 | Pathology | No | 2018-02-21 |
| Slide Stainer, Immersion Type | KIO | Class 1 | Pathology | No | 2019-02-15 |
| Formulations, Paraffin, All | KEO | Class 1 | Pathology | No | 2021-06-25 |
| Dispensers, Paraffin | IDW | Class 1 | Pathology | No | 2025-07-14 |
| Fixative, Formalin-Containing | LDY | Class 1 | Pathology | No | 2018-10-18 |
| Mounting Media | LEB | Class 1 | Pathology | No | 2019-03-07 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2018-09-25 |
| Agent, Clearing | KEM | Class 1 | Pathology | No | 2019-02-19 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2018-07-20 |
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2015-12-18 |
Proprietary Names
CytoPath Disc
IDL - MICROTOME, ACCESSORIES
MXT - DEVICE, ACCESSORY, COOLING PLATE FOR TISSUE EMBEDDING STATION
Galileo Series 2
Tissue cassettes
Donatello Series 2
Empty tank for PWD (wax drain) for Donatello Tissue Processor - Series 2
Donatello Series
Empty tank for PWD (wax drain) for Donatello Series
GreenFix
KIO - SLIDE STAINER, IMMERSION TYPE
Paraffin 56-58 C RFID Donatello Series 2
Paraffin 56-58 C
Paraffin 56-58 C RFID Donatello Series 3
Dante Embedding Module
LDY - FIXATIVE, FORMALIN-CONTAINING
Formalin tank for Donatello Tissue Processor - series 2
Red safety capsule, pre-filled with formalin
Formalin tank for Donatello Tissue Processor - series 3
SafeCapsule Prostate Biopsy Kit
LEB - MOUNTING MEDIA
Cristallo
NNK - CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE
Microclearing tank for Donatello Tissue Processor - Series 2
KEM - AGENT, CLEARING
Ottix Plus tank for Donatello Tissue Processor - Series 2
Xylol tank 5LT for Donatello Tissue Processor - Series 2
Diasolv tank for Donatello Tissue Processor - Series 2
Microclearing tank for Donatello Tissue Processor - Series 3
Ottix Plus tank for Donatello Tissue Processor - Series 3
Xylol tank 5LT for Donatello Tissue Processor - Series 3
Diasolv tank for Donatello Tissue Processor - Series 3
Bottle with blue screw cap, pre-filled with buffer solution
Histoalcol 70 tank for Donatello Tissue Processor - Series 2
Ottix Shaper tank for Donatello Tissue Processor - Series 2
Water tank for Donatello Tissue processor - series 2
Histoalcol 99 tank for Donatello Tissue Processor - Series 2
Histoalcol 95 tank for Donatello Tissue Processor - Series 2
Ottix Shaper tank for Donatello Tissue Processor - Series 3
Histoalcol 95 tank for Donatello Tissue Processor - Series 3
Histoalcol 70 tank for Donatello Tissue Processor - Series 3
Histoalcol 99 tank for Donatello Tissue Processor - Series 3
Water tank for Donatello Tissue processor - series 3
Barrier Remover Solution
Transition Reagent
KPA - Slide stainer, automated
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device