ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non
ETEST® Imipenem/Relebactam (IPR) - ETEST® Imipenem/Relebactam (IPR)
Device Description
A graduated test strip or collection of reagents containing a specified concentration gradient of a specific antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection, excluding mycobacterial infection) intended to be used to determine the minimum inhibitory concentration (MIC) for a particular microorganism, isolated from a clinical specimen by culture.
Environmental Conditions
- -19.00
- -31.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: JWY
Device Name: Manual Antimicrobial Susceptibility Test Systems
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: MI
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: 866.1640
Third Party Flag: Y
Medical Specialty: MI
Device IdentifiersDevice Id: 03573026623753
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 03573026624026
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 03573026624026
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
Device Id: 03573026624293
Device Type: Unit of Use
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
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