Cholesterol Reagent (CHOL 2 x 300)
EUDAMEDFDA UDIClass IVD General (EU MDR)
Identity
- Trade Name
- Cholesterol Reagent (CHOL 2 x 300) EUDAMEDSynchron FDA UDI
- Generic Name
- Total cholesterol lipid IVD, kit, spectrophotometry FDA UDI
- Device Name
- Cholesterol Reagent (CHOL 2 x 300) EUDAMEDFDA UDI
- Model / Reference
- 467825 EUDAMEDFDA UDI
- Description
- Cholesterol Reagent (CHOL 2 x 300) FDA UDI
Identifiers
- Catalog Number
- 467825 FDA UDI
- Primary DI / UDI-DI
- D-467825RN EUDAMED15099590575113 FDA UDI
- Basic UDI-DI
- B-467825RN EUDAMED
- FDA Product Code
- CHH FDA UDI
- EMDN Code
- W01010205 CHOLESTEROL EUDAMED
- GMDN Term
- Total cholesterol lipid IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1175 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Total cholesterol lipid IVD, reagent
Cholesterol Reagent (CHOL 2 x 300) by Beckman Coulter, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total cholesterol lipid IVD, reagent.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-467825RN | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Inc.
- EUDAMED SRN
- US-MF-000010288
- Authorised Representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Sources (2)
- EUDAMED ffa3f520-1a03-422e-9673-19a336df3c0b 61 fields · synced Jun 18, 2026
- FDA UDI 3b0e8200-ccbd-42f4-9635-a6bd3b00bcc8 34 fields · synced May 30, 2026