CELL
CELL-DYN - 01H78-02
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of the white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen using a manual, semi-automated or automated cell count 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: GGK
Device Name: Products, Red-Cell Lysing Products
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
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: 864.8540
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 00380740001148
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00380740135720
Package Quantity: 4
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 00380740135720
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