SULFOLYSER is a reagent for the automated determination of hemoglobin concentration of blood with Sysmex automated hematology analyzers.

SULFOLYSER is a reagent for the automated determination of hemoglobin concentration of blood with Sysmex automated hematology analyzers.
SULFOLYSER - BJ350971

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of total haemoglobin (totHb) in a clinical specimen.

• Total Volume: 1.5 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: 84987562422971

Device Type: Unit of Use

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

Device Id: 04987562422975

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