The PREVI Color Gram is an in vitro diagnostic medical device for professional use. It has been designed to gram stain specimen smears on microscope slides.
PREVI® COLOR GRAM V2 - 414292
Device Description
An automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.
Environmental Conditions
- 40.00
- 0.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: KPA
Device Name: Slide Stainer, Automated
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: PA
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: 864.3800
Third Party Flag: N
Medical Specialty: PA
Device IdentifiersDevice Id: 03573026415310
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