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MAS® Bilirubin Liquid Assayed Bilirubin Control
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref BC102
Identity
- Trade Name
- MAS Bilirubin Liquid Assayed Bilirubin Control FDA UDI
- Generic Name
- Total bilirubin IVD, control FDA UDI
- Device Name
- MAS® Bilirubin Liquid Assayed Bilirubin Control EUDAMED
- Model / Reference
- BC102 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883003842 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883003842 EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0101050203 BILIRUBIN CONTROLS EUDAMED
- GMDN Term
- Total bilirubin 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
No
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
New Device
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® Bilirubin Liquid Assayed Bilirubin 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-00884883003842 | 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 ba57e5ec-52ec-4b80-bcbf-74bf8aca9296 61 fields · synced Jun 9, 2026
- FDA UDI 237430f0-64e2-4358-b143-1630cd23e015 32 fields · synced May 30, 2026