NaCl 0.85 % Medium and Suspension Medium are designed to be used as suspension media with API ®, ID 32 or ATB™ products.
API® NaCl 0.85% Medium - API® NaCl 0.85 % Medium
Device Description
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the differentiation and/or identification of one or multiple species of oxidase negative, gram negative bacteria belonging to the Enterobacteriaceae family, that have been isolated by culture from a clinical specimen.
Environmental Conditions
- 30.00
- 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: JTO
Device Name: Discs, Strips And Reagents, Microorganism Differentiation
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
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: 866.2660
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 03573026047696
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 03573026588465
Package Quantity: 100
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 03573026588465
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