Data / Medical devices / Italy / ELITechGroup S.p.A.
ELITechGroup S.p.A.: FDA-registered device maker in Torino Piedmont, Italy, 1 510(k) clearance
ELITechGroup S.p.A. is registered with the FDA (registration 3011461582) in Torino Piedmont, Italy. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 29, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011461582
- Address
- Corso Svizzera 185, Torino Piedmont, Italy, 10149
- Owner or operator
- ELITechGroup Inc. (1717966)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 5, 2018
- Registered through
- 2026
- Brand names listed
- Elite InGenius, Elite InGenius PCR Cassette, Elite InGenius SP 200, Elite InGenius SP 200 Consumable, Elite InGenius Waste Box
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples | PGI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Real Time Nucleic Acid Amplification System | OOI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 29, 2018 | K180559 | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius | PGI | Substantially Equivalent | Elitechgroup | accessdata.fda.gov |
Compare with other makers
- All makers of Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
- All makers of Real Time Nucleic Acid Amplification System
Updated October 29, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.