LABType™ SSO Class II DRB3,4,5 Typing Test - Sample RSSO2345S

GUDID 00814695024292

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: 00814695024292
• NIH Device Record Key: 7a53d4f6-bd3c-424b-bc0b-b2d744783abf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LABType™ SSO Class II DRB3,4,5 Typing Test - Sample
• Version Model Number: N/A
• Catalog Number: RSSO2345S
• 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	00814695024292 [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

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