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MAS® ChemTRAK H Unassayed Liquid Unassayed Chemistry Control
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref CHU-2
Identity
- Trade Name
- MAS ChemTRAK H Unassayed Liquid Unassayed Chemistry Control FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
- Device Name
- MAS® ChemTRAK H Unassayed Liquid Unassayed Chemistry Control EUDAMED
- Model / Reference
- CHU-2 EUDAMEDFDA UDICHU-1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883003767 EUDAMEDFDA UDI00884883003774 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883003767 EUDAMEDB-00884883003774 EUDAMED
- FDA Product Code
- JJY FDA UDI
- EMDN Code
- W0101050201 ENZYME CONTROLS EUDAMED
- GMDN Term
- Multiple-type clinical chemistry analyte profile 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® ChemTRAK H Unassayed Liquid Unassayed Chemistry 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-00884883003767 | 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 787d227a-54fa-4aee-8b30-f212d1fb961a 61 fields · synced Jul 9, 2026
- FDA UDI cc2cbadc-1579-4b39-989a-88dc9359d346 32 fields · synced May 26, 2026
- FDA UDI b51bc8d7-c213-4f32-9732-c72a1a90ae58 32 fields · synced May 30, 2026
- EUDAMED 95f2d47f-1bea-46b6-8eb5-fd9cbd61b0e6 61 fields · synced Jul 9, 2026