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MAS® CardioImmune XL Liquid Assayed Cardiac Marker Control
EUDAMEDFDA UDIFDA 510(k)Class IVD General (EU MDR)
Ref CAI-XLS
Identity
- Trade Name
- MAS CardioImmune XL Liquid Assayed Cardiac Marker Control FDA UDI
- Generic Name
- Multiple cardiac marker IVD, control FDA UDI
- Device Name
- MAS® CardioImmune XL Liquid Assayed Cardiac Marker Control EUDAMED
- Model / Reference
- CAI-XLS EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883003613 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883003613 EUDAMED
- FDA Product Code
- JJY FDA UDI
- EMDN Code
- W0102152004 CARDIAC MARKER CONTROLS EUDAMED
- GMDN Term
- Multiple cardiac marker IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MAS® CardioImmune XL Liquid Assayed Cardiac Marker Control by Microgenics Corporation — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA GUDID, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061196 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-00884883003613 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- EUDAMED SRN
- US-MF-000030375
- Authorised Representative
- B·R·A·H·M·S GmbH DE-AR-000026031
Sources (3)
- EUDAMED 1d90a470-61f0-4002-87ce-3a8fdc2111fa 61 fields · synced Jul 9, 2026
- FDA UDI 990349c7-831f-4d51-b5df-595a75557a0b 32 fields · synced May 30, 2026
- FDA 510(k) K061196 1 fields · synced May 18, 2026