Data / Medical devices / Ireland / Privapath Diagnostics Ltd
Privapath Diagnostics Ltd: FDA-registered device maker in Dublin 11 Dublin(County), Ireland, 5 510(k) clearances
Privapath Diagnostics Ltd is registered with the FDA (registration 3015209536) in Dublin 11 Dublin(County), Ireland. It lists 9 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 2, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015209536
- Address
- Unit 1, Northern Cross Business Park North Road, Dublin 11 Dublin(County), Ireland, D11 XT26
- Owner or operator
- LetsGetChecked Inc. (10056783)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- January 23, 2018
- Registered through
- 2026
- Brand names listed
- LetsGetChecked Blood Sample Collection Kit, LetsGetChecked Blood and Saliva Collection Kit, LetsGetChecked Blood and Urine Collection Kit, LetsGetChecked ImPress, LetsGetChecked Saliva Sample Collection Kit, LetsGetChecked Stool Sample Collection Kit, LetsGetChecked Swab Sample Collection Kit, LetsGetChecked Urine Sample Collection Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Manufacturer | accessdata.fda.gov |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | 2 | Manufacturer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Manufacturer | accessdata.fda.gov |
| Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay | SEP | 2 | Manufacturer | accessdata.fda.gov |
| Dna Specimen Collection, Saliva | OYJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Manufacturer | accessdata.fda.gov |
| System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home | QYA | 2 | Manufacturer | accessdata.fda.gov |
| Test, Vaginal, Bacterial Sialidase | MXB | 1 | Manufacturer | accessdata.fda.gov |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 2, 2026 | K260184 | Onclarity Self-Collection Kit | SEP | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| January 13, 2025 | K242680 | LetsGetChecked Impress | FMK | Unknown | Privapath Diagnostics Ltd (Dba Letsgetchecked) | accessdata.fda.gov |
| November 15, 2023 | DEN200070 | Simple 2 Test | QYA | Unknown | Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) | accessdata.fda.gov |
| October 27, 2022 | K212745 | ORAcollect®Dx | OYJ | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
| February 19, 2015 | K141410 | ORAGENE DX OGD-500.001 | OYJ | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 1, 2019 | 83709 | Class II | Terminated | Universal Sexual Health Testing Kit | A supplier informed PrivaPath Diagnostics that there is a potential for damaged tubes which could result in blood exposure or erroneous results due to an inappropriate blood-to-additive ratio. | accessdata.fda.gov |
Compare with other makers
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Urine Collection Kit (Excludes Hiv Testing)
- All makers of Blood Specimen Collection Convenience Kit (Excludes Hiv)
- All makers of Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
- All makers of Dna Specimen Collection, Saliva
Updated April 2, 2026. 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.