SULFOLYSER

GUDID 80664369200158

Reagent for the automated determination of hemoglobin concentration of blood

SYSMEX CORPORATION

Total haemoglobin (totHb) IVD, reagent

• Primary Device ID: 80664369200158
• NIH Device Record Key: 6276849c-28e2-4b9e-9550-3069c9a35385
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SULFOLYSER
• Version Model Number: SLS-210A
• Company DUNS: 690664461
• Company Name: SYSMEX CORPORATION
• Device Count: 3
• 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)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com

Device Dimensions

• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter

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
• 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	10664369200159 [Primary]
GS1	80664369200158 [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: 2022-11-14
• Device Publish Date: 2022-11-04

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