ANCA BP FA Test System - Ethanol Fixed Substrate - 420 Tests 100420-11

GUDID M749100420111

ANCA BP FA Test System - Ethanol Fixed Substrate - 420 Tests

IMMUNO CONCEPTS INC

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

• Primary Device ID: M749100420111
• NIH Device Record Key: 200d330b-8cd3-431b-8dec-9e33659268d3
• Commercial Distribution Discontinuation: 2022-01-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ANCA BP FA Test System - Ethanol Fixed Substrate - 420 Tests
• Version Model Number: 100420-11
• Catalog Number: 100420-11
• 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	M749100420111 [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: 2
• Public Version Date: 2025-06-06
• Device Publish Date: 2022-01-05

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