STROMATOLYSER-IM

GUDID 04987562200269

STROMATOLYSER-IM is lyse reagent for the IMI channel of Sysmex Automated Hematology Analyzers.

SYSMEX CORPORATION

Blood cell lysis reagent IVD

• Primary Device ID: 04987562200269
• NIH Device Record Key: 32b11833-5a48-45c5-9499-4727557b9e1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STROMATOLYSER-IM
• Version Model Number: 93403213
• Company DUNS: 690664461
• Company Name: SYSMEX CORPORATION
• Device Count: 1
• 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: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987562200269 [Primary]

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 [STROMATOLYSER-IM]

• 00664369200268: Lysing reagent for analysis of immature WBC
• 04987562200269: STROMATOLYSER-IM is lyse reagent for the IMI channel of Sysmex Automated Hematology Analyzers.