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MAS® CardioImmune XL Liquid Assayed Cardiac Marker Control
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref CAI-XL2Model CAI-XL1
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-XL1 EUDAMEDFDA UDICAI-XL2 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883002340 EUDAMEDFDA UDI00884883002357 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883002340 EUDAMEDB-00884883002357 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 — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00884883002340 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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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 (4)
- EUDAMED d011f707-d3cb-4f1b-ab6d-d2f5524360b1 61 fields · synced Oct 6, 2026
- FDA UDI d0828f85-3e5c-4a0b-81b8-91347d44df25 32 fields · synced May 30, 2026
- FDA UDI 949da4fc-88de-4136-8075-0e10c6888fc6 32 fields · synced May 30, 2026
- EUDAMED 504454a2-af65-42c7-bf10-f90dd9ebe556 61 fields · synced Jun 18, 2026