SULFOLYSER

GUDID 84987562422971

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

SYSMEX CORPORATION

Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent Total haemoglobin (totHb) IVD, reagent

• Primary Device ID: 84987562422971
• NIH Device Record Key: 05d2ab06-7085-421e-a985-be0b3460266f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SULFOLYSER
• Version Model Number: BJ350971
• Company DUNS: 690664461
• Company Name: SYSMEX CORPORATION
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com

Device Dimensions

• Total Volume: 1.5 Liter
• Total Volume: 1.5 Liter
• Total Volume: 1.5 Liter
• Total Volume: 1.5 Liter
• Total Volume: 1.5 Liter
• Total Volume: 1.5 Liter
• Total Volume: 1.5 Liter
• Total Volume: 1.5 Liter

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987562422975 [Primary]
GS1	84987562422971 [Unit of Use]

FDA Product Code

• GGK: Products, Red-Cell Lysing Products

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-08
• Device Publish Date: 2022-11-30

On-Brand Devices [SULFOLYSER]

• 80664369200158: Reagent for the automated determination of hemoglobin concentration of blood
• 00664369200169: Reagent for the automated determination of hemoglobin concentration of blood
• 84987562422971: SULFOLYSER is a reagent for the automated determination of hemoglobin concentration of blood wit