Identity
- Trade Name
- 4Kscore Test FDA UDI
- Generic Name
- Blood collection set, noninvasive FDA UDI
- Device Name
- 4Kscore Specimen Collection Kit FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 4Kscore Specimen Collection Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850038860004 FDA UDI
- PMA Number
- P190022 FDA UDI
- FDA Product Code
- QRF FDA UDI
- GMDN Term
- Blood collection set, noninvasive FDA UDI
Classification
- Device Class
- Class III 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
Yes
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood collection set, noninvasive
4Kscore Test by BioReference Health, LLC — Class III — 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 III | Pending data |
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Manufacturer
- Manufacturer
- BioReference Health, LLC
Sources (1)
- FDA UDI 4ab5f4eb-e9ab-4aa6-9429-04285e472680 35 fields · synced Jun 8, 2026