The Simplex instrument automates placement of up to 6 different Etest strips from foam packaging directly onto agar plates.
Applicator - Simplex C76 - 559802
Device Description
A mains electricity (AC-powered) device intended to be used to position and apply test strips impregnated with antimicrobial agents onto agar plates, or other culture media, for the determination of the minimum inhibitory concentration (MIC) for a particular microorganism, isolated from a clinical specimen by culture.
Environmental Conditions
- 60.00
- -20.00
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: 03573026250768
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