Alinity h
Alinity - 09P8301
Device Description
A device designed to be inserted into an automated microscope slide processing instrument (e.g., microscope slide maker) to create a blood smear on a microscope examination slide for subsequent staining and/or microscopic analysis. It is in the form of a cassette tape with a roll of spaced blades which individually make contact with a single blood drop to produce a smear. This is a reusable device intended to be discarded after all blades have been used once.
Environmental Conditions
- 30.00
- 15.00
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: 00380740132545
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