BioArray Assay Imaging SystemTM (AIS) 400C 790-20006

GUDID 10888234102205

BIOARRAY SOLUTIONS LTD

Microarray analyser IVD, semi-automated

• Primary Device ID: 10888234102205
• NIH Device Record Key: 1a9e98e7-c6cb-443a-883b-159e1d6f1df9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioArray Assay Imaging SystemTM (AIS) 400C
• Version Model Number: 790-20006
• Catalog Number: 790-20006
• 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
• Storage 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	10888234102205 [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: 2014-09-24

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• 10888234100669 - Filled Vial, HEA 1.2 PCR Mix: 2018-07-06
• 10888234100683 - Filled Vial, Lambda Exonuclease: 2018-07-06
• 10888234100836 - Filled Vial,Negative Control 1mL: 2018-07-06
• 10888234100928 - Filled Vial,HotStarTaq DNA Polymerase: 2018-07-06
• 10888234102205 - BioArray Assay Imaging SystemTM (AIS) 400C: 2018-07-06
• 10888234102205 - BioArray Assay Imaging SystemTM (AIS) 400C: 2018-07-06