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Gentamicin

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
Gentamicin FDA UDI
Generic Name
Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
20737844322 FDA UDI

Identifiers

Catalog Number
20737844322 FDA UDI
Primary DI / UDI-DI
04015630915712 FDA UDI
510(k) Number
K945523 FDA UDI
FDA Product Code
LCQ 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

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

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

Gentamicin by Roche Diagnostics Corp. — 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
Roche Diagnostics Corp.

Sources (1)

  • FDA UDI 76582a0f-87b9-4513-8d44-a1258abe39b7 35 fields · synced May 30, 2026