Flow-Count 1 x 21mL A91346

GUDID 15099590390471

Flow-Count Fluorospheres

Beckman Coulter, Inc.

Non-blood cell primer/calibrator/control material IVD, reagent

• Primary Device ID: 15099590390471
• NIH Device Record Key: 49792b1a-30a8-46fe-9035-cb4fa95598d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flow-Count 1 x 21mL
• Version Model Number: A91346
• Catalog Number: A91346
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590390471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954688

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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