ExpertCor Routine

GUDID 00864608000226

ExpertCor Routine plasma set consists of unassayed, ready-to-use human plasmas across reportable range of prothrombin time (PT), activated partial thromboplastin time (APTT), Fibrinogen and INR. The plasma set is intended for use in the quality control of coagulation assay performed on Coagulation Analyzers.

DSRV Inc

Multiple coagulation factor IVD, control

• Primary Device ID: 00864608000226
• NIH Device Record Key: 77f6612c-44d3-46f6-ab85-f40823ee9921
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExpertCor Routine
• Version Model Number: 01306
• Company DUNS: 079613839
• Company Name: DSRV Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
GS1	00864608000226 [Primary]

FDA Product Code

• OHQ: Multi-Analyte Controls Unassayed

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: 2024-05-29
• Device Publish Date: 2024-05-21