Immucor Precise TypeTM Human Erythrocyte Antigen M 800-20202-08

GUDID 10888234100065

BIOARRAY SOLUTIONS LTD

Multiple blood group genotyping IVD, kit, microarray

• Primary Device ID: 10888234100065
• NIH Device Record Key: 167eec6c-fc59-403d-8124-72fd92bd6e58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immucor Precise TypeTM Human Erythrocyte Antigen M
• Version Model Number: 800-20202-08
• Catalog Number: 800-20202-08
• 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: true
• 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

• Special Storage Condition, Specify: Between 0 and 0 *store reagent box in -80 to -20 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store carrier box in 2 to 8 degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234100065 [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

On-Brand Devices [Immucor Precise TypeTM Human Erythrocyte Antigen M]

• 10888234102618: 800-20202-96
• 10888234100065: 800-20202-08