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Product Classification

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Device

activated partial thromboplastin

Regulation Description

Partial thromboplastin time tests.

Regulation Medical Specialty

Hematology

Review Panel

Hematology

Product Code

GFO

Submission Type

510(k)

Regulation Number

864.7925

Device Class

2

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Recognized Consensus Standards

CLSI H47-A2 One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline
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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