ANCA Test System 10700-11

GUDID M74910700111

ANCA BP FA Test System - Ethanol Fixed Substrate - 700 Tests

IMMUNO CONCEPTS INC

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

• Primary Device ID: M74910700111
• NIH Device Record Key: c32fc001-4d8f-476f-819b-5ee30d9f3172
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANCA Test System
• Version Model Number: 10700-11
• Catalog Number: 10700-11
• 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	M74910700111 [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: 2019-11-06
• Device Publish Date: 2016-09-24

On-Brand Devices [ANCA Test System]

• M74910700111: ANCA BP FA Test System - Ethanol Fixed Substrate - 700 Tests
• M749100211121: pANCA Positive Control - 2 x 1 ml.
• M7491003121: ANCA Negative Control - 2 x 1 ml.
• M749100211221: cANCA Positive Control - 2 x 1 ml.
• M7490083141: Custom - ANCA BP FA Test System - Formalin Fixed Substrate - 1400 Tests
• M7490083101: Custom - ANCA BP FA Test System - Formalin Fixed Substrate - 140 Tests
• M74910350111: ANCA BP FA Test System - Ethanol Fixed Substrate - 350 Tests
• M74910140111: ANCA FA Test System - Ethanol Fixed Substrate - 140 wells
• M74910140121: ANCA FA Test System - Formalin Fixed Substrate - 140 wells
• M749100261221: cANCA Titratable Control - PR3 2 x 0.25ml
• M749100261121: pANCA Titratable Control - MPO - 2 x 0.25ml
• M74910700121: ANCA BP FA Test System - Formalin Fixed Substrate - 700 Tests
• M74910350121: ANCA BP FA Test System - Formalin Fixed Substrate - 350 Tests
• M7491010011: ANCA Sample Diluent 1 x 100mls
• M74910070121: ANCA FA Test System - Formalin Fixed Substrate - 70 wells
• M74910070111: ANCA FA Test System - Ethanol Fixed Substrate - 70 wells
• M749100091111: ANCA IgG Fluorescent Antibody Reagent - 1 x 9 mls.
• M7490083091: Custom - ANCA BP FA Test System - Ethanol Fixed Substrate - 1400 Tests
• M749102100111: ANCA BP FA Test System - Ethanol Fixed Substrate - 2100 Tests