FDA Registration
Active
🇺🇸 United States
LetsGetChecked Inc
Reg #: 3042854290
·
FEI: 3042854290
·
Expires 2026
Products
9
Proprietary Names
10
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- LetsGetChecked Inc
- Registration Number
- 3042854290
- FEI Number
- 3042854290
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- Suite 300, 8407 Firebird Dr, Fairfield, OH 45011, USA
- City
- City View Heights
- State
- OH
- ZIP
- 45011
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242680
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | Class 2 | Clinical Chemistry | No | 2018-01-23 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2019-03-22 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2025-03-11 |
| 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 |
| Dna Specimen Collection, Saliva | OYJ | Class 2 | Clinical Chemistry | No | 2024-05-08 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2025-05-23 |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | Class 1 | Pathology | No | 2019-03-06 |
| Test, Vaginal, Bacterial Sialidase | MXB | Class 1 | Microbiology | No | 2019-03-22 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2020-04-03 |
Proprietary Names
LetsGetChecked Blood Sample Collection Kit
LetsGetChecked Blood and Saliva Collection Kit
LetsGetChecked Stool Sample Collection Kit
LetsGetChecked Saliva Sample Collection Kit
LetsGetChecked ImPress
Simple 2 Test
LetsGetChecked Multisite Sample Collection Kit
LetsGetChecked Urine Sample Collection Kit
LetsGetChecked Vaginal Sample Collection Kit
LetsGetChecked Swab Sample Collection Kit
Establishment Types
Complaint File Establishment per 21 CFR 820.198