CEDIA Gentamicin II (GENTC)
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- CEDIA Gentamicin II (GENTC) FDA UDI
- Generic Name
- Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- CEDIA Gentamicin II Assay (100 tests) EUDAMED
- Model / Reference
- 09026924190 EUDAMED09026924 190 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07613336190807 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07613336190807 EUDAMED
- 510(k) Number
- K913470 FDA UDI
- FDA Product Code
- LCD FDA UDI
- EMDN Code
- W0102080307 GENTAMICIN EUDAMED
- GMDN Term
- Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3450 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
CEDIA Gentamicin II (GENTC) by Microgenics Corporation — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA).
- Gentamicin — Roche Diagnostics Corp. · Class II
- Syva® Emit® 2000 Gentamicin Plus Assay — Siemens Healthcare Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- GENT — Randox Laboratories, Ltd. · Class II
- ADVIA® Chemistry GENT_2 Gentamicin_2 Reagents — Siemens Healthcare Diagnostics · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Microgenics Corporation
Sources (2)
- FDA UDI f216b32e-ad0e-44aa-bb86-6d6e9b2378ba 33 fields · synced Jul 15, 2026
- EUDAMED 430de1ff-6d96-4bde-a586-fd8d65287024 61 fields · synced Jul 15, 2026