LABType™ XR Class I C Locus Typing Test - Sample RSSOX1CS

GUDID 00814695024322

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.

ONE LAMBDA, INC.

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

• Primary Device ID: 00814695024322
• NIH Device Record Key: 0bbf80b7-9dc2-428a-b2b7-5f10ffab74b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LABType™ XR Class I C Locus Typing Test - Sample
• Version Model Number: N/A
• Catalog Number: RSSOX1CS
• 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 -80 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814695024322 [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: 2018-04-16
• Device Publish Date: 2018-03-16

On-Brand Devices [LABType™ XR Class I C Locus Typing Test - Sample]

• 00814695024346: HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matchi
• 00814695024322: HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matchi