Presage ST2 Assay Kit

GUDID 00867556000195

CRITICAL CARE DIAGNOSTICS, INC.

Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00867556000195
• NIH Device Record Key: b96ab811-3216-4d27-b070-eab0586743a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Presage ST2 Assay Kit
• Version Model Number: BC-1066x
• Company DUNS: 017390799
• Company Name: CRITICAL CARE DIAGNOSTICS, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 877-700-1250
• Email: orders@criticaldiagnostics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867556000195 [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: 2018-07-11
• Device Publish Date: 2016-10-18

Devices Manufactured by CRITICAL CARE DIAGNOSTICS, INC.

• 00867556000157 - EIA Test Kit: 2018-07-11
• 00867556000171 - PRESAGE ST2 Controls Kit: 2018-07-11
• 00867556000188 - EIA Test Kit: 2018-07-11
• 00867556000195 - Presage ST2 Assay Kit: 2018-07-11
• 00867556000195 - Presage ST2 Assay Kit: 2018-07-11