← Back to catalogue
MAS CardioImmune XL Liquid Assayed Cardiac Marker Control
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 10014179
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
- 10014179 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883004368 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883004368 EUDAMED
- FDA Product Code
- JJY FDA UDI
- EMDN Code
- W0101050202 LIPID 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
No
FDA UDI
Human Tissues
No
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
New Device
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-00884883004368 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Microgenics Corporation
- EUDAMED SRN
- US-MF-000030375
- Authorised Representative
- B·R·A·H·M·S GmbH DE-AR-000026031
Sources (2)
- EUDAMED 2ab8e2df-82ee-400c-a514-dc2df43e3c15 61 fields · synced Jul 17, 2026
- FDA UDI adaf6ea9-cf8b-4f3d-b3d0-18e9093bfe12 32 fields · synced May 27, 2026