Identity
- Trade Name
- LetsGetChecked Blood Sample Collection Kit (MHTB) FDA UDI
- Generic Name
- Capillary blood collection kit IVD FDA UDI
- Device Name
- A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device. FDA UDI
- Model / Reference
- BO12S FDA UDI
- Description
- A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- BO12S FDA UDI
- Primary DI / UDI-DI
- 00810111410175 FDA UDI
- FDA Product Code
- PQD FDA UDI
- GMDN Term
- Capillary blood collection kit IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Capillary blood collection kit IVD
LetsGetChecked Blood Sample Collection Kit (MHTB) by Privapath Diagnostics Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Privapath Diagnostics Limited
Sources (1)
- FDA UDI 2eba0585-94ca-47a9-820f-93d8308fd74d 34 fields · synced Jun 7, 2026