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MAS® UrichemTRAK Liquid Assayed Urine Control
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 10014127Ref UR11001Ref UR22002
Identity
- Trade Name
- MAS® UrichemTRAK Liquid Assayed Urine Control FDA UDIMAS UrichemTRAK Liquid Assayed Urine Control FDA UDI
- Generic Name
- Multiple urine analyte IVD, control FDA UDI
- Device Name
- MAS® UrichemTRAK Liquid Assayed Urine Control EUDAMED
- Model / Reference
- 10014127 EUDAMEDFDA UDIUR22002 EUDAMEDFDA UDIUR11001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883004405 EUDAMEDFDA UDI00884883002487 EUDAMEDFDA UDI00884883002470 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883004405 EUDAMEDB-00884883002470 EUDAMEDB-00884883002487 EUDAMED
- FDA Product Code
- JJW FDA UDI
- EMDN Code
- W0101050101 ASSAYED MULTICOMPONENT CONTROLS (CC) EUDAMED
- GMDN Term
- Multiple urine analyte 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 UDIFDA UDI
Human Tissues
Yes
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
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® UrichemTRAK Liquid Assayed Urine 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-00884883004405 | 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 (6)
- EUDAMED 70d1932d-bfaf-4cc5-af90-7fb2878098d2 61 fields · synced Aug 2, 2026
- FDA UDI 8a8ec923-5830-419e-b903-81e85ea8f735 32 fields · synced May 30, 2026
- FDA UDI b6189a61-b3f8-457d-876c-d4d6ac8dafac 32 fields · synced May 30, 2026
- FDA UDI c98182fb-e481-40f0-b60d-bf6995ff3b34 32 fields · synced May 30, 2026
- EUDAMED 8a79ef1c-7aa1-46ea-9228-b6f07c8119ef 61 fields · synced Jul 17, 2026
- EUDAMED b2ea0ab4-ceff-4e00-b75e-df83bd557296 61 fields · synced Jul 23, 2026