← Back to catalogue

QMS Amikacin Immunoassay

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 0373910

by Microgenics Corporation

Identity

Trade Name
QMS Amikacin Immunoassay FDA UDI
Generic Name
Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
QMS Amikacin Immunoassay EUDAMED
Model / Reference
0373910 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
00884883005983 EUDAMEDFDA UDI
Basic UDI-DI
B-00884883005983 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 EUDAMED
Class 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 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Microgenics Corporation
EUDAMED SRN
US-MF-000030375
Authorised Representative
B·R·A·H·M·S GmbH DE-AR-000026031

Sources (2)

  • EUDAMED 90221887-d3d0-4bbd-97ff-49f99d3df6c9 61 fields · synced Jul 20, 2026
  • FDA UDI 2992b830-6523-4d83-8070-7110f6c11557 33 fields · synced May 29, 2026