Lysing reagent for hematology analyzers

Lysing reagent for hematology analyzers
STROMATOLYSER-4DL - FFD-200A

A substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.

• Total Volume: 5 Liter

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00664369201418

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