AggreDYNE AA Assay

GUDID 20856893004014

AA Assay Cartridge, Single Use Packaged

AGGREDYNE, INC.

Platelet aggregation study IVD, reagent

• Primary Device ID: 20856893004014
• NIH Device Record Key: ada84b0d-15e2-4956-9608-c381fe0e0224
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AggreDYNE AA Assay
• Version Model Number: A-100
• Company DUNS: 078703793
• Company Name: AGGREDYNE, 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: false
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856893004010 [Primary]
GS1	10856893004017 [Package]; Contains: 00856893004010; Package: Case [20 Units]; In Commercial Distribution
GS1	20856893004014 [Package]; Contains: 00856893004010; Package: Case [20 Units]; In Commercial Distribution

FDA Product Code

• JOZ: System, Automated Platelet Aggregation

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: 2019-02-01
• Device Publish Date: 2019-01-01

Devices Manufactured by AGGREDYNE, INC.

• 00856893004027 - Aggreguide: 2019-10-01 AggreDYNE A-100 ADP Assay
• 20856893004014 - AggreDYNE AA Assay: 2019-02-01AA Assay Cartridge, Single Use Packaged
• 20856893004014 - AggreDYNE AA Assay: 2019-02-01 AA Assay Cartridge, Single Use Packaged
• 00856893004041 - Aggreguide: 2019-02-01 Whole Blood Aggregometer