Privapath Diagnostics Ltd
Dublin 11, IE
Privapath Diagnostics Ltd appears in FDA device records in Dublin 11, IE. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015209536 | 3015209536 | Privapath Diagnostics Ltd | Unit 1, Northern Cross Business Park, Dublin 11 Dublin(County) D11 XT26 IE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KXGApplicator, Absorbent Tipped, Sterile
- PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)
- NNKContainer, Specimen Mailer And Storage, Non-Sterile
- SEPDevice For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
- OYJDna Specimen Collection, Saliva
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- QYASystem For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
- MXBTest, Vaginal, Bacterial Sialidase
- OIEUrine Collection Kit (Excludes Hiv Testing)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0350-2020 | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain