Identity
- Trade Name
- Totle Cholesterol (TC) Test Kit (Oxidase) EUDAMEDBIOBASE FDA UDI
- Generic Name
- Total cholesterol lipid IVD, reagent FDA UDI
- Device Name
- Totle Cholesterol (TC) Test Kit (Oxidase) EUDAMED
- Model / Reference
- R1:64mL×2 R2:16mL×2(70152) EUDAMEDR1:64mL×2 R2:16mL×2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936895301882 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06936895301882 EUDAMED
- FDA Product Code
- CHH FDA UDI
- EMDN Code
- W01010205 CHOLESTEROL EUDAMED
- GMDN Term
- Total cholesterol lipid IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1175 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Total cholesterol lipid IVD, reagent
Biobase by Biobase Biodustry(Shandong)Co., Ltd. — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Total cholesterol lipid IVD, reagent.
- FORA — FORA CARE INC. · Class I
- OS-CHOL — PZ CORMAY Spółka Akcyjna · IVD General
- Cholesterol (CHOL) Assay Kit (Oxidase Method) — YHLO BIOTECH (NANJING) CO., LTD. · IVD General
- 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
- Cholesterol – Liquizyme CHOD-PAP — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
- Total Cholesterol Assay Kit (Oxidase Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong)Co., Ltd.
Sources (2)
- FDA UDI 28f935c8-3134-4ab6-aa8f-dd3d1d2b15b5 32 fields · synced Oct 5, 2026
- EUDAMED 716dbc69-b5f1-4702-9696-fa2776804092 61 fields · synced Oct 5, 2026