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Hematology › Automated Hematology DevicesPlasma, Coagulation Control

STA® – System Control N + P

Catalogue number 00678, listed by Diagnostica Stago, Inc., United States, under Plasma, Coagulation Control. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

2recalls on this 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 STA® – System Control N + P
Listed by	Diagnostica Stago, Inc., United States
FDA product code	GGN
Device type	Plasma, Coagulation Control
Device class	Class 2
Regulation	21 CFR 864.5425
Establishment	Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K943518
Record published	2016-09-15
Record revised	2026-05-18 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for STA® – System Control N + P
Catalogue number	Size	Status
00678		In distribution

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
K120014	2013-03-14
K010324	2001-04-09
K010350	2001-04-09

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of STA® – System Control N + P
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Diagnostica Stago, Inc.	510(k) number	2019-11-18	Class II	Process control	A positive bias was confirmed to exists on the STA – Unicalibrator levels with STA – Deficient IX and STA – Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several Externa	5,437	2023-01-12
Diagnostica Stago, Inc.	510(k) number	2011-08-23	Not classified	Nonconforming Material/Component	Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P.	1259 units	2013-09-04

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.