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Citrine™ QTRAP MS/MS
EUDAMEDFDA UDIClass A (EU MDR)
Ref 5050807Model Citrine™ MS/MS System
Identity
- Trade Name
- Citrine™ QTRAP MS/MS EUDAMEDCitrine QTRAP MS/MS FDA UDI
- Generic Name
- Mass spectrometry analyser IVD FDA UDI
- Device Name
- Citrine™ Triple Quad MS/MS EUDAMEDThe Citrine 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
- Citrine™ MS/MS System EUDAMED5050807 EUDAMEDFDA UDI
- Description
- The Citrine 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
- 00842365100540 EUDAMEDFDA UDI
- Basic UDI-DI
- 08423651CitrinePJ 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
Citrine™ QTRAP MS/MS 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 | 08423651CitrinePJ | 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 f21b75ec-cc42-4227-b0a8-00d9f99574a0 61 fields · synced Jun 17, 2026
- FDA UDI e28081d8-48e3-4a0f-84ad-a7b06ac9861f 33 fields · synced May 29, 2026