Plasma, Coagulation Control

Which Manufacturers in China Make This?

3 manufacturers in China hold an FDA registration for this device type, based in Shandong and Shanghai.

What Is FDA Product Code GGN?

Plasma, Coagulation Control is FDA product code GGN, Class 2, 21 CFR 864.5425.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 16 recalls under this product code since 2010. None was by a company in China. The root causes the FDA records most often are Error in labeling (6), Process control (3) and No Marketing Application (3).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Plasma, Coagulation Control

GEM Check Coag Control-Abnormal for ACT

Catalogue number 06260060300, listed by Instrumentation Laboratory SPA, Italy, under Plasma, Coagulation Control. 3 manufacturers in China are registered for this product code.

Plasma, Coagulation Control

K-Assay® Fibrinogen Control

For use as a consistent test sample of known concentration for monitoring assay conditions for fibrinogen.

Plasma, Coagulation Control

Pool Norm

Catalogue number 01139, listed by Diagnostica Stago, Inc., United States, under Plasma, Coagulation Control. 3 manufacturers in China are registered for this product code.

Plasma, Coagulation Control

QuikCoag Control Level 3 High Abnormal

Catalogue number 1 mL, listed by Biomedica Diagnostics Inc., Canada, under Plasma, Coagulation Control. 3 manufacturers in China are registered for this product code.

Plasma, Coagulation Control

Coagulation S.a.r.p (Specialty Assayed Reference Plasma)

Catalogue number 5185, listed by Helena Laboratories, Corp., United States, under Plasma, Coagulation Control. 3 manufacturers in China are registered for this product code.

Plasma, Coagulation Control

directCHECK ACT-LR Whole Blood Controls, Level 1

directCHECK GH100 ACTLRL1 15/box.

Plasma, Coagulation Control

VisuCon-L(TM) Normal Control Plasma

A pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.05M HEPES and stabilizers, dispensed and lyophilized. This plasma is used for the quality…

Plasma, Coagulation Control

Pefakit

Control plasma for assays aimed to determine the functional phenotype for activated protein C resistance caused by the Factor V Leiden mutation (FV:Q506).

Plasma, Coagulation Control

Xprecia™ System PT Controls

The Xprecia™ System PT Controls; For use with Xprecia System, supplying assayed controls for prothrombin time (PT).

Plasma, Coagulation Control

Biophen UFH Control C2

Catalogue number 223901, listed by Hyphen Biomed, United States, under Plasma, Coagulation Control. 3 manufacturers in China are registered for this product code.

Plasma, Coagulation Control

Which Manufacturers in China Make This?

What Is FDA Product Code GGN?

What Does It Take to Sell It in the United States?

What Do the Recalls Say?

Where China Actually Supplies