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QMS Everolimus Immunoassay
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 0380005
Identity
- Trade Name
- QMS Everolimus Immunoassay FDA UDI
- Generic Name
- Rapamycin (sirolimus) therapeutic drug monitoring IVD, calibrator FDA UDI
- Device Name
- QMS Everolimus Immunoassay EUDAMED
- Model / Reference
- 0380005 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883000537 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883000537 EUDAMED
- FDA Product Code
- OUF FDA UDI
- EMDN Code
- W0102080606 EVEROLIMUS EUDAMED
- GMDN Term
- Rapamycin (sirolimus) therapeutic drug monitoring IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3840 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 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
QMS Everolimus Immunoassay by Microgenics Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00884883000537 | 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 b0c61f4b-4c9b-4bd3-abc9-e1174198c9e6 61 fields · synced Jun 19, 2026
- FDA UDI 51ea7439-0550-4119-9568-6a4ee81329e5 32 fields · synced May 30, 2026