Who else makes this device?

Name: VisuCon-L Coag Screen N Plasma
Brand: VisuCon-L Coag Screen N Plasma

Hematology › Automated Hematology DevicesPlasma, Coagulation Control

VisuCon-L Coag Screen N Plasma

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

Registry build 21.09.26

A pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.05M HEPES buffer and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays (PT, APTT and Fibinogen) in the normal range.

3manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shandong (2), Shanghai (1).

Chinese manufacturers registered for FDA product code GGN
Manufacturer	City	Province	Registered as	Device types
Infitek Co., Ltd.	Shanghai	Shanghai	Manufacturer	49
Labpeak Co., Ltd.	Jinan	Shandong	Manufacturer	43
Scitek Global Co., Ltd.	Jinan	Shandong	Manufacturer	43

Record

Regulatory record for VisuCon-L Coag Screen N Plasma
Listed by	Affinity Biologicals Inc., Canada
FDA product code	GGN
Device type	Plasma, Coagulation Control
Device class	Class 2
Regulation	21 CFR 864.5425
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2018-10-19
Record revised	2026-05-18 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C
Distribution end date	2024-03-31

Catalogue Numbers

Catalogue numbers for VisuCon-L Coag Screen N Plasma
Catalogue number	Size	Per pack	Status
LSCN01		10	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
George King Pooled Normal Plasma	George King BIO-Medical, Inc.	15
directCHECK Whole Blood Controls	Accriva Diagnostics, Inc.	12
Thermo Scientific Pacific Hemostasis®	Fisher Diagnostics	8
Lyphochek	Bio-Rad Laboratories Inc.	8
George King Single Donor Normal Plasma	George King BIO-Medical, Inc.	7
Validate	LGC Clinical Diagnostics, Inc.	6
George King Coumadin® Plasma	George King BIO-Medical, Inc.	5
Plasma, Coagulation Control	Medtronic, Inc.	5
Liquichek	Bio-Rad Laboratories Inc.	5
CueSee® Coag	Eurotrol B.V.	5
Rotem®	TEM Innovations GmbH	4
CRYOcheck™ Pooled Normal Plasma	Precision BioLogic Inc.	4

Showing 12 of 129. All products under Plasma, Coagulation Control

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K150144	2016-03-06
K110432	2011-10-20
K091284	2009-10-28

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.