COULTER ReticPrep 7546978

GUDID 15099590221126

COULTER ReticPrep Reagent Kit

Beckman Coulter, Inc.

Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent

• Primary Device ID: 15099590221126
• NIH Device Record Key: 171fd8ae-96f9-4a95-8968-c43b7341f86f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COULTER ReticPrep
• Version Model Number: 7546978
• Catalog Number: 7546978
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590221126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925344

FDA Product Code

• GKZ: Counter, Differential Cell

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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