LABType™ SSO Class II DPA1/DPB1 Typing Test - Sample RSSO2PS

GUDID 00814695024261

DNA typing of HLA Class I or Class II alleles.

ONE LAMBDA, INC.

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

• Primary Device ID: 00814695024261
• NIH Device Record Key: 85f0156f-22fd-47bd-8471-eb45f007ed0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LABType™ SSO Class II DPA1/DPB1 Typing Test - Sample
• Version Model Number: N/A
• Catalog Number: RSSO2PS
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814695024261 [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: 2017-04-28

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