COULTER Lyse S 4 Lytic Reagent 8547147

GUDID 15099590624736

COULTER Lyse S 4 Lytic Reagent (5L)

Beckman Coulter, Inc.

Full blood count IVD, reagent

• Primary Device ID: 15099590624736
• NIH Device Record Key: 55a9e636-16c3-4e9c-9866-6bbbf120c19d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COULTER Lyse S 4 Lytic Reagent
• Version Model Number: 8547147
• Catalog Number: 8547147
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590624736 [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: 2020-09-08
• Device Publish Date: 2020-08-31

On-Brand Devices [COULTER Lyse S 4 Lytic Reagent]

• 15099590624743: COULTER Lyse S 4 Lytic Reagent (1L )
• 15099590624736: COULTER Lyse S 4 Lytic Reagent (5L)