HEp-2000® IgG Fluorescent ANA-Ro Test System 8303-Ro

GUDID M7498303RO1

Custom - HEp-2000® IgG FA w/cs ANA-Ro Bulk Pack - 1050 Tests

IMMUNO CONCEPTS INC

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay

• Primary Device ID: M7498303RO1
• NIH Device Record Key: 2ac9901d-9100-4023-8310-de57c52b24d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEp-2000® IgG Fluorescent ANA-Ro Test System
• Version Model Number: 8303-Ro
• Catalog Number: 8303-Ro
• 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	M7498303RO1 [Primary]

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: 2022-08-17
• Device Publish Date: 2022-08-09

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• M7498291RO1: Custom - HEp-2000® IgG FA w/cs ANA-Ro BP - 1400 Tests
• M7498283RO1: Custom - HEp-2000® IgG FA w/cs ANA-Ro Super BP - 6300 Tests
• M7498232RO1: Custom - HEp-2000® IgG FA ANA-Ro Super BP - 4200 Tests
• M7498198RO1: Custom - HEp-2000® IgG ANA-Ro FA -280 wells
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• M7492000CS21RO1: HEp-2000® IgG FA w/cs ANA-Ro Bulk Pack - 2100 Tests
• M7498202RO1: Custom - HEp-2000® IgG FA ANA-Ro BP - 1800 Tests
• M7492145GRO1: HEp-2000® IgG Fluorescent ANA-Ro Test System - 140 Tests
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• M7498321RO1: Custom - HEp-2000® IgG FA w/cs ANA-Ro BP - 6300 wells
• M7498320RO1: Custom - HEp-2000® IgG FA w/cs ANA-Ro BP - 6300 wells
• M7498319RO1: Custom - HEp-2000® IgG FA w/cs ANA-Ro Bulk Pack - 2100 Tests
• M7498315RO1: Custom - HEp-2000® IgG FA w/cs ANA-Ro BP - 6300 wells
• M7498300CSRO1: Custom - HEp-2000® IgG FA w/cs ANA-Ro Super BP - 6300 Tests
• M7498290RO1: Custom - HEp-2000® IgG FA w/cs ANA-Ro Super BP - 4200 Tests
• M7498286RO1: Custom - HEp-2000® IgG FA ANA-Ro BP - 6300 wells
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• M7498279RO1: Custom - HEp-2000® IgG FA ANA-Ro BP - 1800 Tests
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• M7492000G14RO1: HEp-2000® IgG Fluorescent ANA-Ro Bulk Pack - 1400 Tests
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