Gentamicin

Gentamicin
ARCHITECT - 1E11-20

Device Description

A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug gentamicin in a clinical specimen, using a chemiluminescent immunoassay method.

Environmental Conditions

Handling Environment Temperature - Degrees Celsius

29.00
N/A

Special Storage Condition, Specify

Do not freeze reagents or expose reagents to temperatures above 32 degrees celcius.

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LCD

Device Name: Enzyme Immunoassay, Gentamicin

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: TX

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.3450

Third Party Flag: Y

Medical Specialty: TX

Device Identifiers

Device Id: 00380740000301

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A