Identity
- Trade Name
- QMS Amikacin Assay FDA UDI
- Generic Name
- Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- QMS Amikacin Assay EUDAMED
- Model / Reference
- 10017196 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883012660 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883012660 EUDAMED
- 510(k) Number
- K052815 FDA UDI
- FDA Product Code
- KLQ FDA UDI
- EMDN Code
- W0102080301 AMIKACIN EUDAMED
- GMDN Term
- Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3035 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
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 Amikacin Assay 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-00884883012660 | 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 e7888b51-af85-4518-baf3-8f6639340561 61 fields · synced Jun 18, 2026
- FDA UDI d43dda88-81bd-44fa-b082-3ee47a9f0cf2 33 fields · synced May 30, 2026