MONOFLUO 32515

GUDID 00847865001519

MONOFLUO Pneumocystis jirovecii (P. carinii) IFA Test

Bio-RAD Laboratories, Inc.

Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT)

• Primary Device ID: 00847865001519
• NIH Device Record Key: 8e59ef7c-0f02-43b5-81ab-3d1cd584975c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONOFLUO
• Version Model Number: 32515
• Catalog Number: 32515
• Company DUNS: 844766394
• Company Name: Bio-RAD Laboratories, 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: true
• Device Combination Product: false
• Single Use: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)224-6723
• Email: TechSupport.USSD-Redmond@bio-rad.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847865001519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890768

FDA Product Code

• LYF: PNEUMOCYSTIS CARINII

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: 2016-09-12

On-Brand Devices [MONOFLUO]

• 00847865001519: MONOFLUO Pneumocystis jirovecii (P. carinii) IFA Test
• 00847865001502: MONOFLUO Fluorescence Microscopy Slides