Identity
- Trade Name
- L-Type HDL-C Reagent 2 FDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, calibrator FDA UDI
- Device Name
- In-Vitro Diagnostic Use FDA UDI
- Model / Reference
- 993-72691 FDA UDI
- Description
- In-Vitro Diagnostic Use FDA UDI
Identifiers
- Catalog Number
- 993-72691 FDA UDI
- Primary DI / UDI-DI
- 14987481164595 FDA UDI
- 510(k) Number
- K963847 FDA UDI
- FDA Product Code
- LBR FDA UDI
- GMDN Term
- High density lipoprotein (HDL) cholesterol IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1475 FDA UDI
- 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
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
Category: High density lipoprotein (HDL) cholesterol IVD, calibrator
L-Type HDL-C Reagent 2 by Fujifilm Wako Pure Chemical Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as High density lipoprotein (HDL) cholesterol IVD, calibrator.
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- Ultra N-geneous HDL Cholesterol Calibrator — Sekisui Diagnostics, LLC · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- VITROS — Ortho-Clinical Diagnostics · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class I
Cleared under the same submission
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fujifilm Wako Pure Chemical Corporation
Sources (2)
- FDA UDI 06d95a0e-7ba8-4dac-88a5-86581681f2a7 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026