FDA Registration
Active
🇮🇪 Ireland
Privapath Diagnostics Ltd
Reg #: 3015209536
·
FEI: 3015209536
·
Expires 2026
Products
9
Proprietary Names
10
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- Privapath Diagnostics Ltd
- Registration Number
- 3015209536
- FEI Number
- 3015209536
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit 1, Northern Cross Business Park, North Road
- City
- Dublin 11
- Country
- IE
Regulatory Submissions
- 510(k) Number
- DEN200070
Owner / Operator
- Firm Name
- LetsGetChecked Inc.
- Operator Number
- 10056783
- Address
- PrivaPath Diagnostics Ltd t/a Lets Get Checked 3rd Floor, Block 1, West Pier Business Campus,, Dun Laoghaire Co.Dublin A96 F8C0
- City
- Dublin
- State
- IE-D
- Postal Code
- A96 F8C0
- Country
- IE
- Correspondent
- Karen Walsh
US Agent
- Business Name
- Pro Pharma Group
- Contact Name
- Cherita James
- Address
- 1129 20th St Nw Ste 600
- City
- Washington
- State
- DC
- ZIP
- 20036
- Country
- US
- [email protected]
- Phone
- 347 9540624
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home | QYA | Class 2 | Microbiology | No | 2024-11-29 |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | Class 1 | Pathology | No | 2019-03-06 |
| Dna Specimen Collection, Saliva | OYJ | Class 2 | Clinical Chemistry | No | 2024-05-08 |
| Test, Vaginal, Bacterial Sialidase | MXB | Class 1 | Microbiology | No | 2019-03-22 |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | Class 2 | Clinical Chemistry | No | 2018-01-23 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2025-03-11 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2025-05-23 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2019-03-22 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2020-04-03 |
Proprietary Names
Simple 2 Test
LetsGetChecked Urine Sample Collection Kit
LetsGetChecked Saliva Sample Collection Kit
LetsGetChecked Vaginal Sample Collection Kit
LetsGetChecked Blood Sample Collection Kit
LetsGetChecked Blood and Saliva Collection Kit
LetsGetChecked ImPress
LetsGetChecked Multisite Sample Collection Kit
LetsGetChecked Stool Sample Collection Kit
LetsGetChecked Swab Sample Collection Kit
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device