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Gent

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
GENT FDA UDI
Generic Name
Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
For the quantitative in vitro determination of Gentamicin in human serum FDA UDI
Model / Reference
TD3413 FDA UDI
Description
For the quantitative in vitro determination of Gentamicin in human serum FDA UDI

Identifiers

Catalog Number
TD3413 FDA UDI
Primary DI / UDI-DI
05055273206449 FDA UDI
510(k) Number
K012978 FDA UDI
FDA Product Code
LCD FDA UDI
GMDN Term
Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Category: Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Gent by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Randox Laboratories, Ltd.

Sources (1)

  • FDA UDI d19fb425-e6a2-4574-b667-6b7687659efc 37 fields · synced Jun 6, 2026