Identity
- Trade Name
- Yumizen C1200 HDL Direct FDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 1300023852 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230007044 FDA UDI
- 510(k) Number
- K060854 FDA UDI
- FDA Product Code
- LBR FDA UDI
- GMDN Term
- High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry 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
No
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, kit, spectrophotometry
Yumizen C1200 HDL Direct by Horiba Abx — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry.
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- CAROLINA LIQUID CHEMISTRIES CORP.® HDL RGT. KIT BL-616 — Carolina Liquid Chemistries Corp. · Class I
- HDL Ultra Cholesterol — Sekisui Diagnostics, LLC · Class I
- Sirrus® Direct HDL Cholesterol LiquiColor® — STANBIO LABORATORY, L.P. · Class I
- Dimension Vista® Flex® reagent cartridge HDLC — Siemens Healthcare Diagnostics · Class I
- CAROLINA LIQUID CHEMISTRIES CORP.® HDLD RGT. KIT AU-616 — Carolina Liquid Chemistries Corp. · Class I
Cleared under the same submission
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 I | Pending data |
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Manufacturer
- Manufacturer
- Horiba Abx
Sources (1)
- FDA UDI bc123391-a5c0-445b-9026-d427f6c2d4b9 33 fields · synced Jun 6, 2026