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QMS Everolimus Immunoassay
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 10015987
Identity
- Trade Name
- QMS Everolimus Assay FDA UDI
- Generic Name
- Rapamycin (sirolimus) therapeutic drug monitoring IVD, reagent FDA UDI
- Device Name
- QMS Everolimus Immunoassay EUDAMED
- Model / Reference
- 10015987 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883011854 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883011854 EUDAMED
- 510(k) Number
- K122766 FDA UDI
- FDA Product Code
- OUF FDA UDI
- EMDN Code
- W0102080606 EVEROLIMUS EUDAMED
- GMDN Term
- Rapamycin (sirolimus) therapeutic drug monitoring IVD, reagent 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
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
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-00884883011854 | 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 4cca67af-a97b-41bd-993b-54018e690d08 61 fields · synced Jul 13, 2026
- FDA UDI 5e02efe4-7d93-4165-9449-a7f9a8742e3a 33 fields · synced May 30, 2026