Identity
- Trade Name
- AU FDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, calibrator FDA UDI
- Device Name
- HDL Cholesterol Calibrator FDA UDI
- Model / Reference
- ODC0023 FDA UDI
- Description
- HDL Cholesterol Calibrator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590070502 FDA UDI
- 510(k) Number
- K040692 FDA UDI
- FDA Product Code
- JIT 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
- 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
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
Yes
FDA UDI
Category: High density lipoprotein (HDL) cholesterol IVD, calibrator
Au by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as High density lipoprotein (HDL) cholesterol IVD, calibrator.
- CHOLESTEROL HDL 2G CALIBRATOR — VITALSCIENTIFIC
- Atellica CH HDLC CAL — Siemens Healthcare Diagnostics · Class II
- ENVOY 500 HDL CALIBRATOR KIT — VITALSCIENTIFIC
- 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
- L-Type HDL-C Reagent 1 — FUJIFILM WAKO PURE CHEMICAL CORPORATION · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class I
Cleared under the same submission
K040692 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI 70a80d1f-7de0-4327-bb05-8801105ca635 34 fields · synced Jun 8, 2026