Identity
- Trade Name
- QUCARE®Self Total Cholesterol FDA UDI
- Generic Name
- Total cholesterol lipid IVD, reagent FDA UDI
- Model / Reference
- 6400P FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806141302674 FDA UDI
- GMDN Term
- Total cholesterol lipid IVD, reagent 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Total cholesterol lipid IVD, reagent
QUCARE®Self Total Cholesterol by Dfi Co., Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total cholesterol lipid IVD, reagent.
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- HeartsCare C1 Total Cholesterol Test Strip (10pcs/box) — Hearts Bio, Inc. · Class I
- Teco Diagnostics Cholesterol TC-Matrix-480 — TECO DIAGNOSTICS · Class I
- DIRUI — DIRUI INDUSTRIAL CO., LTD · IVD General
- Liquick Cor-CHOL 30 — PZ CORMAY Spółka Akcyjna · IVD General
- Total Cholesterol (TC) — Maccura Biotechnology Co., Ltd. · IVD General
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
- Dfi Co., Ltd
Sources (1)
- FDA UDI b5972d9a-f4b4-4be0-a813-2719e90fc550 33 fields · synced May 30, 2026