Identity
- Trade Name
- CHOLESTEROL LDL 2G CALIBRATOR FDA UDI
- Generic Name
- Low density lipoprotein (LDL) cholesterol IVD, calibrator FDA UDI
- Model / Reference
- LDLL-0041 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540215704 FDA UDI
- GMDN Term
- Low density lipoprotein (LDL) cholesterol IVD, calibrator FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
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: Low density lipoprotein (LDL) cholesterol IVD, calibrator
Cholesterol Ldl 2g Calibrator by Vitalscientific — IVDR, IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Low density lipoprotein (LDL) cholesterol IVD, calibrator.
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- Yumizen C1200 LDL Cal — Horiba Abx · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | N/A | Unknown |
| EUDAMED | European Union | IVDD | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Vitalscientific
Sources (2)
- FDA UDI 756961d4-f35d-40dc-bf5f-da5a78bdd054 32 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 4, 2026