CELL
CELL-DYN - 03H40-01
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of reticulocyte red blood cells in a clinical specimen using a manual, semi-automated or automated cell count method.
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: GJH
Device Name: Stain, Reticulocyte
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: HE
Review Code: N/A
Technical Method: Y
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.1850
Third Party Flag: N
Medical Specialty: HE
Device Identifiers
Device Id: 00380740005009
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
