Identity
- Trade Name
- Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal) EUDAMEDBIOBASE FDA UDI
- Generic Name
- Low density lipoprotein (LDL) cholesterol IVD, reagent FDA UDI
- Device Name
- Low-density Lipoprotein Cholesterol (LDL-C) Test Kit(Direct-Surfactant Removal) EUDAMED
- Model / Reference
- R1:18mL×4 R2:6mL×4(710) EUDAMEDR1:18mL×4 R2:6mL×4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971674860730 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971674860730 EUDAMED
- FDA Product Code
- MRR FDA UDI
- EMDN Code
- W01010222 NON ESTERIFIED FATTY ACIDS EUDAMED
- GMDN Term
- Low density lipoprotein (LDL) cholesterol IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1475 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Low density lipoprotein (LDL) cholesterol 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 Low density lipoprotein (LDL) cholesterol IVD, reagent.
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
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 ef86ac60-5691-47a6-8a1d-6976b62d2e66 32 fields · synced Jul 20, 2026
- EUDAMED be5acf64-097f-4b41-b68b-38d08edecb32 61 fields · synced Jul 20, 2026