UniMatch™ Plus Software 790111

GUDID 00814695022496

UniMatch PLUS Software analyzes the reaction patterns of UniTray™ and AllSet+™ Gold kits for the determination of Human Leukocyte Antigens (HLA) allele assignment by comparison to the IMGT/HLA database.

ONE LAMBDA, INC.

HLA class I & II antigen tissue typing IVD, kit, multiplex HLA class I & II antigen tissue typing IVD, kit, multiplex

• Primary Device ID: 00814695022496
• NIH Device Record Key: 0ef24a5f-674b-41e9-93b9-8126531e1c61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UniMatch™ Plus Software
• Version Model Number: N/A
• Catalog Number: 790111
• Company DUNS: 118289289
• Company Name: ONE LAMBDA, INC.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 800.822.8244
• Email: techsupport@onelambda.com
• Phone: 800.822.8244
• Email: techsupport@onelambda.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814695022496 [Primary]

FDA Product Code

• MZI: Test,Qualitative,For Hla,Non-Diagnostic

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: 2019-01-23
• Device Publish Date: 2016-08-31

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