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MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control
EUDAMEDFDA UDIClass IVD Annex II List B (EU MDR)
Ref OPRO-303
Identity
- Trade Name
- MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
- Device Name
- MAS Omni-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control EUDAMED
- Model / Reference
- OPRO-303 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883005341 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883005341 EUDAMED
- FDA Product Code
- JJY FDA UDI
- EMDN Code
- W01021521 MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS EUDAMED
- GMDN Term
- Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
Classification
- Device Class
- Class IVD Annex II List B 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
No
EUDAMED
Microbial Substances
No
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-IMMUNE PRO Liquid Assayed Integrated Immunoassay Control by Microgenics Corporation — Class IVD Annex II List B — IVDD, FDA UDI — listed in EUDAMED…
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-00884883005341 | Class IVD Annex II List B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD Annex II List B | 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 087eb471-cb51-4465-b690-aa58ec6e1d9d 61 fields · synced Jul 28, 2026
- FDA UDI 358ee909-08eb-4b59-b93e-2ed94c4d182c 32 fields · synced May 30, 2026