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ADVIA® Chemistry CHOL_c Cholesterol Reagents, Concentrated
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- ADVIA® Chemistry CHOL_c Cholesterol Reagents, Concentrated FDA UDI
- Generic Name
- Total cholesterol lipid IVD, kit, spectrophotometry FDA UDI
- Device Name
- Cholesterol - ADVIA Chem. - Conc. RGT - 4x2100/4x1340 tests FDA UDI
- Model / Reference
- 10335874 FDA UDI
- Description
- Cholesterol - ADVIA Chem. - Conc. RGT - 4x2100/4x1340 tests FDA UDI
Identifiers
- Catalog Number
- 4993681 FDA UDI
- Primary DI / UDI-DI
- 00630414526744 FDA UDI
- 510(k) Number
- K923504 FDA UDI
- FDA Product Code
- CHH FDA UDI
- GMDN Term
- Total cholesterol lipid IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1175 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: Total cholesterol lipid IVD, kit, spectrophotometry
ADVIA® Chemistry CHOL_c Cholesterol Reagents, Concentrated by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Total cholesterol lipid IVD, kit, spectrophotometry.
- Pointe Cholesterol Reagent — POINTE SCIENTIFIC, INC. · Class I
- STANDARD™ LipidoCare Analyzer — Sd Biosensor · Class I
- STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile — Sd Biosensor · Class I
- Cholesterol Gen.2 — Roche Diagnostics Corp. · Class I
- Cholesterol LiquiColor® — STANBIO LABORATORY, L.P. · Class I
- Cholesterol LiquiColor® — STANBIO LABORATORY, L.P. · Class I
- POINTE SCIENTIFIC Cholesterol (Liquid) — POINTE SCIENTIFIC, INC. · Class I
- CHOLESTEROL (CHOL) — Randox Laboratories, Ltd. · Class I
Cleared under the same submission
K923504 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 56ef0dfc-66b7-40ea-9005-3caafde80bfb 37 fields · synced May 30, 2026