Stem
Stem-Kit Reagents - IM3630US
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations, using a fluorescent activated cell sorting/flow cytometry (FACS/Flow) method.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GKZ
Device Name: Counter, Differential Cell
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HE
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: 864.5220
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 15099590762889
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