STROMATOLYSER-4DL

GUDID 04987562201402

The STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count, or 5-part differential count* and WBC count* with Sysmex automated hematology analyzers (*on XS series only).

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

• Primary Device ID: 04987562201402
• NIH Device Record Key: df268db3-a430-42ab-889b-d821cca204b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STROMATOLYSER-4DL
• Version Model Number: 98417615
• 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: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter
• Total Volume: 5 Liter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987562201402 [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-4DL]

• 00664369201418: Lysing reagent for hematology analyzers
• 04987562407767: The STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count
• 04987562201402: The STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count