LABScan™ 100 Systems LABSCNXS2

GUDID 00812117015699

A sensitive flow analyzer capable of processing up to 100 bead regions simultaneously and when used with One Lambda’s LABType and LABScreen family of products, the system allows the user to make assignments of HLA antibodies as well as HLA typing with the analysis support of HLA Fusion.

ONE LAMBDA, INC.

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

• Primary Device ID: 00812117015699
• NIH Device Record Key: ec196a1d-3493-406e-bee5-f1755abd49a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LABScan™ 100 Systems
• Version Model Number: N/A
• Catalog Number: LABSCNXS2
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812117015699 [Primary]

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

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: 2016-08-31

Devices Manufactured by ONE LAMBDA, INC.

• 00812117015484 - PE-Conjugated Streptavidin: 2020-06-12 For use in the detection of biotinylated proteins and nucleic acids in biotinylated proteins and nucleic acids in LABType™ SSO
• 00812117010199 - LABScreen™ Single Antigen HLA Class I ExPlex: 2020-06-11 LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology
• 00812117014654 - LABScreen™ Single Antigen HLA Class II ExPlex: 2020-06-11 LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology
• 00814695022496 - UniMatch™ Plus Software: 2019-01-23 UniMatch PLUS Software analyzes the reaction patterns of UniTray™ and AllSet+™ Gold kits for the determination of Human Leuk
• 00812117015255 - Adsorb Out: 2018-07-16 To reduce high background that is caused by nonspecific binding of materials in human sera to the latex beads used in flow antib
• 00814695024452 - Micro SSP™ Gel System - 108 Wells: 2018-07-16 The Micro SSP Gel Box System is a compact gel box for electrophoresis.
• 00812117015873 - Fluorobeads™ T Lymphocyte – 25 Isolations: 2018-07-02 FluoroBeads-T provide a simple procedure for the isolation of T lymphocytes for use in microcytotoxicity assays using fluorescen
• 00812117015880 - Fluorobeads™ B Lymphocyte – 25 Isolations: 2018-07-02 FluoroBeads-B provide a simple procedure for the isolation of B lymphocytes for use in HLA Class II typing assays using fluoresc