HEp-2000® Fluorescent ANA-Ro Test System 8295-Ro

GUDID M7498295RO1

Custom: HEp-2000® FA ANA-Ro Super BP - 6300 Tests

IMMUNO CONCEPTS INC

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

• Primary Device ID: M7498295RO1
• NIH Device Record Key: 093eb1ee-a3a7-407c-8b8b-8d0e8d1911a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEp-2000® Fluorescent ANA-Ro Test System
• Version Model Number: 8295-Ro
• Catalog Number: 8295-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	M7498295RO1 [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: 2019-11-14
• Device Publish Date: 2016-09-24

On-Brand Devices [HEp-2000® Fluorescent ANA-Ro Test System]

• M7492700RO1: HEp-2000® Fluorescent ANA-Ro Test System - 700 Tests
• M7490202221: ANA Speckled Positive Control - 2 x 1 ml
• M7498029RO1: Custom - HEp-2000® FA ANA-Ro BP - 700 Tests
• M749200414RO1: HEp-2000® Fluorescent ANA-Ro Bulk Pack - 1400 Tests
• M7492000RO1: HEp-2000® Fluorescent ANA-Ro Bulk Pack - 1300 Tests
• M749200018RO1: HEp-2000® Fluorescent ANA-Ro Bulk Pack - 1800 Tests
• M7490202111: ANA FA Homogeneous Positive Control - 1 x 5 ml
• M7498153RO1: Custom - HEp-2000® FA ANA-Ro BP - 1400 Tests
• M7498127RO1: Custom - HEp-2000® FA ANA-Ro Super BP - 4200 Tests
• M7492075RO11: IgG (H & L) Fluorescent Antibody Reagent 1 x 23 mls.
• M749200014RO1: HEp-2000® Fluorescent ANA-Ro Bulk Pack - 1400 Tests
• M7490202521: ANA Centromere Positive Control - 2 x 1 ml
• M7498248RO1: Custom: HEp-2000® FA ANA-Ro Super BP - 4200 Tests
• M74982071RO1: Custom - HEp-2000® FA ANA-Ro BP - 1800 Tests
• M7498096RO1: Custom - HEp-2000® FA ANA-Ro BP - 1400 Tests
• M7490204111: ANA Optional Control - Scl-70 AB - 1 x 0.5 ml
• M7498300RO1: Custom - HEp-2000® FA ANA-Ro Super BP - 6300 Tests
• M7498296RO1: Custom - HEp-2000® FA ANA-Ro Super BP - 6300 Tests
• M74981491RO1: Custom - HEp-2000® FA ANA-Ro BP - 5400 Wells
• M7498084RO1: Custom - HEp-2000® Fluorescent ANA-Ro BP - 4200 Tests
• M7492040RO1: HEp-2000® Fluorescent ANA-Ro Test System - 70 Tests
• M7492010011: ANA Sample Diluent 1 x 100mls
• M7492002RO1: HEp-2000® Fluorescent ANA-Ro Bulk Pack - 1300 Tests
• M7490203711: ANA Optional Control - PCNA/Cyclin AB - 1 x 0.5 ml
• M7490203511: Optional Universal Control - SSA 1 x 1 ml
• M7490203111: ANA FA Negative Control - 1 x 5 ml
• M7490202611: ANA FA Titratable Control - 2 x 0.5 ml
• M7490020321: ANA Control Set - 1 Each of Five Controls
• M7490002001: Serum Diluent 4 x 100ml
• M7498295RO1: Custom: HEp-2000® FA ANA-Ro Super BP - 6300 Tests
• M7498246RO1: Custom- HEp-2000® IgG Fluorescent w/cs ANA-Ro BP - 700 Tests
• M7498224RO1: Custom - HEp-2000® FA ANA-Ro BP - 1300 Tests
• M7498123RO1: Custom - HEp-2000® FA ANA-Ro BP - 5400 wells
• M7498112RO1: Custom - HEp-2000® FA ANA-Ro BP - 1300 Wells
• M7498085RO1: Custom - HEp-2000® FA ANA-Ro BP -1800 Tests
• M749220014RO1: HEp-2000® Fluorescent ANA-Ro Test System - 280 Tests
• M7492100RO1: HEp-2000® Fluorescent ANA-Ro Test System - 130 Tests
• M74920100101: ANA Sample Diluent 10 x 100mls
• M7492004RO1: HEp-2000® Fluorescent ANA-Ro Bulk Pack - 1300 Tests
• M749200214RO1: HEp-2000® Fluorescent ANA-Ro Bulk Pack - 1400 Tests
• M7490202911: ANA Optional Control - Golgi AB - 1 x 0.5 ml
• M7490202711: ANA Optional Control - Mitochondrial AB - 1 x 1.0 ml
• M7490202321: ANA Nucleolar Positive Control - 2 x 1 ml
• M7490084001: Custom: ANA FA Super Bulk Pack - 5400 Tests