LetsGetChecked Stool Sample Collection Kit
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- LetsGetChecked Stool Home Sample Collection Kit EUDAMEDLetsGetChecked Stool Sample Collection Kit FDA UDI
- Generic Name
- Faecal specimen collection kit IVD, home-use FDA UDI
- Device Name
- LetsGetChecked Stool Home Sample Collection Kit EUDAMEDA collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. FDA UDI
- Model / Reference
- FT01I EUDAMEDFT01S, FT102, FT101 FDA UDI
- Description
- A collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. FDA UDI
Identifiers
- Catalog Number
- FT01S, FT102, FT101 FDA UDI
- Primary DI / UDI-DI
- 00850024881259 EUDAMEDFDA UDI
- Basic UDI-DI
- 850024881SCT6 EUDAMED
- FDA Product Code
- NNK FDA UDI
- EMDN Code
- W05019001 FAECES COLLECTION DEVICES EUDAMED
- GMDN Term
- Faecal specimen collection kit IVD, home-use FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
No
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Faecal specimen collection kit IVD, home-use
LetsGetChecked Stool Sample Collection Kit by Privapath Diagnostics Limited — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Privapath Diagnostics Limited
Sources (2)
- FDA UDI f9184137-15dd-4f48-b580-f7ac66f5f238 34 fields · synced Jun 18, 2026
- EUDAMED 137338b5-4c04-40a3-93fd-41d04c8c00e5 61 fields · synced Jun 18, 2026