Filled Vial, HEA 1.2 PCR Mix 800-00194

GUDID 10888234100669

BIOARRAY SOLUTIONS LTD

Multiple blood group genotyping IVD, reagent

• Primary Device ID: 10888234100669
• NIH Device Record Key: 3c3d867f-87bc-413e-9c80-b7ba53d7df62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Filled Vial, HEA 1.2 PCR Mix
• Version Model Number: 800-00194
• Catalog Number: 800-00194
• 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 -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	10888234100669 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP130026

FDA Product Code

• PEP: Molecular Erythrocyte Typing Test

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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