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MAS® CardioImmune Ultra Low Control (6 x 3 mL)
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref CAI-UL
Identity
- Trade Name
- MAS Cardioimmune Ultra Low FDA UDI
- Generic Name
- Troponin T/Troponin I IVD, control FDA UDI
- Device Name
- MAS® CardioImmune Ultra Low Control (6 x 3 mL) EUDAMED
- Model / Reference
- CAI-UL EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883003620 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883003620 EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102152004 CARDIAC MARKER CONTROLS EUDAMED
- GMDN Term
- Troponin T/Troponin I 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 Ultra Low Control (6 x 3 mL) 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-00884883003620 | 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 (2)
- EUDAMED 0f67ab60-1e39-4cf5-b7a1-b006b41d5a5e 61 fields · synced Jun 18, 2026
- FDA UDI a9022404-728a-4328-acc5-5d62f0d89680 32 fields · synced May 30, 2026