FDA UDI
In Commercial Distribution
🇺🇸 United States
LetsGetChecked Blood Sample Collection Kit (TRFN)
DI: 00810111410342
·
Model: BO07S
·
PRIVAPATH DIAGNOSTICS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LetsGetChecked Blood Sample Collection Kit (TRFN)
- Primary DI
- 00810111410342
- Version / Model
- BO07S
- Catalog Number
- BO07S
- Company Name
- PRIVAPATH DIAGNOSTICS LIMITED
- Labeler DUNS
- 985578451
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-30
- Public Version
- 2
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- b8d652cd-4587-4664-81b3-86eda96036b0
Device 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
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65433 | Capillary blood collection kit IVD | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810111410342 | GS1 |