Identity
- Trade Name
- CVS Health At Home FDA UDI
- Generic Name
- Dried blood spot collection kit IVD FDA UDI
- Device Name
- Dry blood spot card collection kit utilizing 903 Five Spot Blood Card and Hologic Aptima Urine transport tube. FDA UDI
- Model / Reference
- STI collection kit FDA UDI
- Description
- Dry blood spot card collection kit utilizing 903 Five Spot Blood Card and Hologic Aptima Urine transport tube. FDA UDI
Identifiers
- Catalog Number
- 50428654200 FDA UDI
- Primary DI / UDI-DI
- 00860008357847 FDA UDI
- FDA Product Code
- LIO FDA UDI
- GMDN Term
- Dried blood spot collection kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2900 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
Yes
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: Sexually transmitted infection (STI) testing specimen collection kit IVD, clinicalBlood collection paperDried blood spot collection kit IVD
CVS Health At Home by Blackfly Investments, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dried blood spot collection kit IVD.
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 I | Pending data |
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Manufacturer
- Manufacturer
- Blackfly Investments, LLC
Sources (1)
- FDA UDI fb2588e9-62f3-4ec1-b6b1-9bff04bf4bc0 34 fields · synced Jun 1, 2026