Identity
- Trade Name
- ADVIA® Chemistry Direct LDL Cholesterol Reagents FDA UDI
- Generic Name
- Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry FDA UDI
- Device Name
- LDL Cholesterol - ADVIA Chem. - RGT - 4x188 tests FDA UDI
- Model / Reference
- 10311891 FDA UDI
- Description
- LDL Cholesterol - ADVIA Chem. - RGT - 4x188 tests FDA UDI
Identifiers
- Catalog Number
- B01-4760-01 FDA UDI
- Primary DI / UDI-DI
- 00630414470542 FDA UDI
- 510(k) Number
- K982529 FDA UDI
- FDA Product Code
- MRR FDA UDI
- GMDN Term
- Low density lipoprotein (LDL) 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: Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry
ADVIA® Chemistry Direct LDL Cholesterol Reagents by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry.
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- LDL CHOL Reagent Kit — Medica Corp. · Class I
- CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT DT661 — Carolina Liquid Chemistries Corp. · Class I
- CHOLESTEROL LDL SL 2G — VITALSCIENTIFIC
- DIRECT LDL-CHOLESTEROL (LDL) — Randox Laboratories, Ltd. · Class I
- LDL-Cholesterol Gen.3 — Roche Diagnostics Corp. · Class I
Cleared under the same submission
K982529 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 50674df5-b9fc-414f-832f-2180e2dffac9 37 fields · synced May 30, 2026