LABScreen™ Mixed Class I & II LSM12

GUDID 00812117011592

LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology

ONE LAMBDA, INC.

HLA class I & II antibody screening IVD, kit, multiplex

• Primary Device ID: 00812117011592
• NIH Device Record Key: 2cca5caf-8bff-4e09-9797-88d7488bf483
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LABScreen™ Mixed Class I & II
• Version Model Number: N/A
• Catalog Number: LSM12
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 800.822.8824
• Email: techsupport@onelambda.com
• Phone: 800.822.8824
• Email: techsupport@onelambda.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -65 Degrees Celsius and -65 Degrees Celsius
• Storage Environment Temperature: Between -65 Degrees Celsius and -65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812117011592 [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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-11

Devices Manufactured by ONE LAMBDA, INC.

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