Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710595

FEI Number

3003400058

Entity Name

GLOBAL INSTRUMENTATION CORP.

City/State/Country

NEW TAIPEI, TW

Establishment Address

14 F., NO. 186, JIAN-YI ROAD, CHUNG-HO DISTRICT, NEW TAIPEI 235, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

GLOBAL INSTRUMENTATION CORP. (Owner Number: 9046757)

Owner / Operator Contact Address

14 F., NO. 186, JIAN-YI ROAD, CHUNG-HO, NEW TAIPEI, TW-NOTA 235, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2013-01-23
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-01-23
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2013-01-23
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-01-23
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2022-01-18
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2018-03-26

Official Correspondent

BO-YI CHEN

US Agent Details

Chung-Ho Shu Email: bradw@gic.com.tw Phone: (408) 3145388

Related Public Records

Same Entity

GLOBAL INSTRUMENTATION CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

Similar Registrations

Registration Number	Establishment Name	Location
3014353121	VIDAN DIAGNOSTICS, LLC	San Antonio, TX, US
1649661	GERMAINE LABORATORIES, INC.	SAN ANTONIO, TX, US
3002637618	Siemens Healthcare Diagnostics Inc	East Walpole, MA, US
3008517993	ZHEJIANG ORIENT GENE BIOTECH	Huzhou Zhejiang, CN
3004193489	NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS	Billerica, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710595. Last updated year: 2026. Please use registration number 9710595 when referencing this establishment in official correspondence.