IMMUNO CONCEPTS 7096-12

GUDID M7497096121

RELISA® ENA Multiparameter Plus Screen Test System - 96 Wells

IMMUNO CONCEPTS INC

Multiple extractable nuclear antigen auto-antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: M7497096121
• NIH Device Record Key: fd33ef43-91a1-4892-a5a8-94dddb7dbe95
• Commercial Distribution Discontinuation: 2016-09-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: IMMUNO CONCEPTS
• Version Model Number: 7096-12
• Catalog Number: 7096-12
• Company DUNS: 038271904
• Company Name: IMMUNO CONCEPTS 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7497096121 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-11
• Device Publish Date: 2016-09-30

On-Brand Devices [IMMUNO CONCEPTS]

• M7491204002R1: Mouse LKS Tissue FA Test System - RUO - 40 Tests
• M7497096121: RELISA® ENA Multiparameter Plus Screen Test System - 96 Wells
• M7491226202R11: APCA Titratable Control - 1 x 0.25 ml
• M74912031R11: Negative Control 1 x 1ml
• M7491111C41: Custom - Universal Mounting Medium - 4 x 5 ml
• M7497696121: RELISA® ENA Multiparameter Plus Screen Test System - 576 Wells
• M7490081311: Custom - EBNA FA BP - 3900 wells