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ADVIA® Chemistry D-HDL Direct HDL Cholesterol Reagents
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- ADVIA® Chemistry D-HDL Direct HDL Cholesterol Reagents FDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry FDA UDI
- Device Name
- HDL Cholesterol - ADVIA Chem. - RGT - 6x670 tests FDA UDI
- Model / Reference
- 10283089 FDA UDI
- Description
- HDL Cholesterol - ADVIA Chem. - RGT - 6x670 tests FDA UDI
Identifiers
- Catalog Number
- 6521559 FDA UDI
- Primary DI / UDI-DI
- 00630414551784 FDA UDI
- 510(k) Number
- K982341 FDA UDI
- FDA Product Code
- LBS 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
No
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
ADVIA® Chemistry D-HDL Direct HDL Cholesterol Reagents by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry.
- Pointe autoHDL Cholesterol Reagent — POINTE SCIENTIFIC, INC. · Class I
- HDL-Cholesterol Gen.4 — Roche Diagnostics Corp. · Class I
- ENVOY 500 HDL CHOLESTEROL REAGENT KIT — VITALSCIENTIFIC
- CAROLINA LIQUID CHEMISTRIES CORP.® HDL RGT. KIT BL-616 — Carolina Liquid Chemistries Corp. · Class I
- HDL Ultra Cholesterol — Sekisui Diagnostics, LLC · Class I
- ABX PENTRA HDL DIRECT CP — Horiba Abx · Class I
- Sirrus® Direct HDL Cholesterol LiquiColor® — STANBIO LABORATORY, L.P. · Class I
- CAROLINA LIQUID CHEMISTRIES CORP.® HDLD RGT. KIT AU-616 — Carolina Liquid Chemistries Corp. · Class I
Cleared under the same submission
K982341 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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 458a4f56-4db1-4288-916c-ed759946dee6 37 fields · synced May 31, 2026