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Product Classification

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Device

protamine sulphate

Regulation Description

Heparin assay.

Regulation Medical Specialty

Hematology

Review Panel

Hematology

Product Code

GFT

Submission Type

510(k)

Regulation Number

864.7525

Device Class

2

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Recognized Consensus Standards

CLSI H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
CLSI H49-A Point-of-Care Monitoring of Anticoagulant Therapy; Approved Guideline
CLSI H49-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline

Third Party Review

Not Third Party Eligible

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