BioArray Assay Imaging System TM (AIS) 400C 790-20006-RF

GUDID 10888234102212

BIOARRAY SOLUTIONS LTD

Microarray analyser IVD, semi-automated

• Primary Device ID: 10888234102212
• NIH Device Record Key: 7db432e8-6c45-4d36-a7c7-d16bf1b99460
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioArray Assay Imaging System TM (AIS) 400C
• Version Model Number: 790-20006-RF
• Catalog Number: 790-20006-RF
• Company DUNS: 949103725
• Company Name: BIOARRAY SOLUTIONS LTD
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Temperature of 15 degrees Celsius to 26.7 degrees Celsius when in use

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234102212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK130051

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

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: 2015-12-28

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