STROMATOLYSER-3WP

GUDID 04987562022090

STROMATOLYSER-3WP is a lysing reagent to eliminate red blood cells and cell stroma for use in accurate determination of WBC counts and tri-modal WBC distribution analysis. STROMATOLYSER-3WP is a clear reagent manufactured for use with selected Sysmex Automated Hematology Analyzers.

SYSMEX CORPORATION

Blood cell lysis reagent IVD

• Primary Device ID: 04987562022090
• NIH Device Record Key: e67f0dba-16eb-4e6a-8e32-a56d820d28cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STROMATOLYSER-3WP
• Version Model Number: 85400121
• 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	04987562022090 [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

Devices Manufactured by SYSMEX CORPORATION

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• 04987562020102 - CELLPACK: 2022-12-08 CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection).
• 04987562020171 - CELLPACK: 2022-12-08 CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection).
• 04987562022090 - STROMATOLYSER-3WP: 2022-12-08STROMATOLYSER-3WP is a lysing reagent to eliminate red blood cells and cell stroma for use in accurate determination of WBC counts and tri-modal WBC distribution analysis. STROMATOLYSER-3WP is a clear reagent manufactured for use with selected Sysmex Automated Hematology Analyzers.
• 04987562022090 - STROMATOLYSER-3WP: 2022-12-08 STROMATOLYSER-3WP is a lysing reagent to eliminate red blood cells and cell stroma for use in accurate determination of WBC coun
• 04987562022335 - STROMATOLYSER-FB: 2022-12-08 STROMATOLYSER-FB is a reagent for analyzing basophil counts and WBC counts by the flow cytometry method, using a semiconductor l
• 04987562200269 - STROMATOLYSER-IM: 2022-12-08 STROMATOLYSER-IM is lyse reagent for the IMI channel of Sysmex Automated Hematology Analyzers.
• 04987562201389 - STROMATOLYSER-4DS: 2022-12-08 STROMATOLYSER-4DS is to be used to stain the leukocytes in diluted and lysed blood samples for determination of the 4-part diffe
• 04987562201402 - STROMATOLYSER-4DL: 2022-12-08 The STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count, or 5-part differential count*