STROMATOLYSER-IM

GUDID 00664369200268

Lysing reagent for analysis of immature WBC

SYSMEX CORPORATION

Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD Blood cell lysis reagent IVD

• Primary Device ID: 00664369200268
• NIH Device Record Key: f7166fa6-fc20-41f8-af58-6e0c060763a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STROMATOLYSER-IM
• Version Model Number: SIM-220A
• 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: true
• 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: 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
• Total Volume: 10 Liter
• Total Volume: 10 Liter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00664369200268 [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: 2022-11-14
• Device Publish Date: 2022-11-04

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.