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Triple Quad™ 4500MD MS/MS System
EUDAMEDFDA UDIClass A (EU MDR)
Ref 5061724Model 4500MD MS/MS System
Identity
- Trade Name
- Triple Quad™ 4500MD MS/MS System EUDAMEDAB SCIEX Triple Quad™ 4500MD FDA UDI
- Generic Name
- Mass spectrometry analyser IVD FDA UDI
- Device Name
- Triple Quad™ 4500MD MS/MS System EUDAMEDThe 4500MD system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or organic compounds in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical field according to their mass. FDA UDI
- Model / Reference
- 4500MD MS/MS System EUDAMED5061724 EUDAMEDFDA UDI
- Description
- The 4500MD system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or organic compounds in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical field according to their mass. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842365102049 EUDAMEDFDA UDI
- Basic UDI-DI
- 084236514500MDP3 EUDAMED
- FDA Product Code
- DOP FDA UDI
- EMDN Code
- W020303 MASS - SPECTROMETRY SYSTEM EUDAMED
- GMDN Term
- Mass spectrometry analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2860 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Triple Quad™ 4500MD MS/MS System by AB SCIEX Pte. Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 084236514500MDP3 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- AB SCIEX Pte. Ltd
- EUDAMED SRN
- SG-MF-000023910
- Authorised Representative
- Leica Microsystems CMS GmbH DE-AR-000021052
Sources (2)
- EUDAMED fd978818-4e5d-443e-8907-3466780b288c 61 fields · synced Jun 18, 2026
- FDA UDI 0dd0da56-aab1-4361-8ea7-66279655d247 33 fields · synced May 30, 2026