Carrier Box, ETC, Slide, IVD 800-20301

GUDID 10888234102670

BIOARRAY SOLUTIONS LTD

Optical instrument calibration/verification reference standard IVD Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable

• Primary Device ID: 10888234102670
• NIH Device Record Key: d8fde59d-e0e1-4293-b117-ac4aea47d355
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carrier Box, ETC, Slide, IVD
• Version Model Number: 800-20301
• Catalog Number: 800-20301
• 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: 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234102670 [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

Devices Manufactured by BIOARRAY SOLUTIONS LTD

• 10888234100065 - Immucor Precise TypeTM Human Erythrocyte Antigen M: 2018-07-06
• 10888234100621 - Filled Vial, Clean-up, 330uL: 2018-07-06
• 10888234100645 - Filled Vial, eMAPTM Elongation Mix: 2018-07-06
• 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