Bartels® B1029-81

GUDID 05391516745871

Bartels® CMV Fluorescent Antibody Test

TRINITY BIOTECH PUBLIC LIMITED COMPANY

Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay

• Primary Device ID: 05391516745871
• NIH Device Record Key: 38809790-081c-4a93-bc73-d6d6d0b48b43
• Commercial Distribution Discontinuation: 2019-01-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Bartels®
• Version Model Number: B1029-81
• Catalog Number: B1029-81
• Company DUNS: 988298840
• Company Name: TRINITY BIOTECH PUBLIC LIMITED COMPANY
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +35312769800
• Email: Infectiousdisease.techsupport@trinitybiotech.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	05391516745871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894002

FDA Product Code

• LIN: Antisera, Conjugated Fluorescent, Cytomegalovirus

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-10
• Device Publish Date: 2016-09-23

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