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MAS T-Marker Liquid Assayed Tumor Marker Control
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- MAS T-Marker Liquid Assayed Tumor Marker Control FDA UDI
- Generic Name
- Multiple tissue-associated protein/tumour marker IVD, control FDA UDI
- Model / Reference
- TUM-202 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883002456 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple tissue-associated protein/tumour marker IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
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
Category: Multiple tissue-associated protein/tumour marker IVD, control
MAS T-Marker Liquid Assayed Tumor Marker Control by Microgenics Corporation — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Microgenics Corporation
Sources (2)
- FDA UDI f9dfdc07-df7a-46b9-94f5-7fff771ff775 32 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 29, 2026