Precise TypeTM HEA BeadCheck Kit 800-20236

GUDID 10888234102632

BIOARRAY SOLUTIONS LTD

Multiple blood group genotyping IVD, control

• Primary Device ID: 10888234102632
• NIH Device Record Key: 966a98a6-985c-42e2-8e87-30bf29907b54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precise TypeTM HEA BeadCheck Kit
• Version Model Number: 800-20236
• Catalog Number: 800-20236
• 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: 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234102632 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK130050

FDA Product Code

• PFK: Quality Control For Molecular Immunohematology Tests

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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