Identity
- Trade Name
- HDL-C/LDL-C Calibrator FDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, calibrator FDA UDI
- Device Name
- In-Vitro Diagnostic Use FDA UDI
- Model / Reference
- 990-28011 FDA UDI
- Description
- In-Vitro Diagnostic Use FDA UDI
Identifiers
- Catalog Number
- 990-28011 FDA UDI
- Primary DI / UDI-DI
- 10856626006035 FDA UDI
- 510(k) Number
- K001005 FDA UDI
- FDA Product Code
- JIS FDA UDI
- GMDN Term
- High density lipoprotein (HDL) cholesterol IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Convenience Kit
No
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
HDL-C/LDL-C Calibrator by Fujifilm Wako Pure Chemical Corporation — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K001005 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fujifilm Wako Pure Chemical Corporation
Sources (2)
- FDA UDI d7632d9c-33a0-46b4-b87f-224d7286a0ff 38 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026