LABScreen™ Single Antigen HLA Class I ExPlex LS1AEX01

GUDID 00812117010199

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

ONE LAMBDA, INC.

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

• Primary Device ID: 00812117010199
• NIH Device Record Key: 0184f24b-6f83-4f5e-9d8f-24c9e9e3b894
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LABScreen™ Single Antigen HLA Class I ExPlex
• Version Model Number: N/A
• Catalog Number: LS1AEX01
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com
• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com
• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com
• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com
• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com
• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com
• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com
• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com
• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com
• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com
• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com
• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com
• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com
• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com
• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com
• Phone: 800.822.8824
• Email: 1lambda-TechSupport@thermofisher.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812117010199 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-11
• Device Publish Date: 2020-06-03

Devices Manufactured by ONE LAMBDA, INC.

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• 00812117010199 - LABScreen™ Single Antigen HLA Class I ExPlex: 2020-06-11LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology
• 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