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MAS® Omni-CORE Liquid Assayed Integrated Chemistry Control
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref OCR-202
Identity
- Trade Name
- MAS Omni-CORE Liquid Assayed Integrated Chemistry Control FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
- Device Name
- MAS® Omni-CORE Liquid Assayed Integrated Chemistry Control EUDAMED
- Model / Reference
- OCR-202 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883005419 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883005419 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® Omni-CORE Liquid Assayed Integrated 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-00884883005419 | 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 3eeeccc3-9da4-4779-b339-894f18136801 61 fields · synced Jul 15, 2026
- FDA UDI 6bd9d438-c261-4e61-b43f-373015053ce4 32 fields · synced May 30, 2026