Identity
- Trade Name
- CHECK UP AMERICA CHOLESTEROL PANEL FDA UDI
- Generic Name
- Capillary blood collection set, home-use FDA UDI
- Device Name
- Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used in the diagnosis and treatment of disorders involving excess cholesterol in the blood. FDA UDI
- Model / Reference
- 80 FDA UDI
- Description
- Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used in the diagnosis and treatment of disorders involving excess cholesterol in the blood. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M769CHOLESTEROL801 FDA UDI
- 510(k) Number
- K063852 FDA UDI
- GMDN Term
- Capillary blood collection set, home-use FDA UDI
Classification
- 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
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 set, home-use
Check Up America Cholesterol Panel by Home Access Health Corp. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Capillary blood collection set, home-use.
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- Everlywell Blood Collection Kit — Everly Health, Inc. · Class II
Cleared under the same submission
K063852 also covers:
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Home Access Health Corp.
Sources (1)
- FDA UDI 2e491e8f-3c11-44e5-b13d-7b4a34133b78 34 fields · synced May 30, 2026