GLYCOMARK

Primary DI: 04987170775562
Brand: GLYCOMARK
Company: NIPPON KAYAKU CO., LTD.
Model: NK-8300
Device description: Kit Reagents1,5-anhydroglucitol (1,5-AG) Enzymatic 1,5-AG Assay for Glycemic Control
Published: 2016-09-24
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true

Contact Domains#

Product Codes#

Code, Name table
Code	Name
NOZ	Assay, 1,5-Anhydroglucitol (15ag)

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
NOZ	Assay, 1,5-Anhydroglucitol (15ag)	Hematology	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K031604	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K031604	000	GLYCOMARK	Tomen America, Inc.	2003-09-22	NOZ

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
04987170775562	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifier	GTIN-14 normalized	EAN-13
04987170775562	04987170775562	4987170775562

GMDN Terms#

Term, Definition table
Term	Definition
1,5-Anhydroglucitol IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of 1,5-anhydroglucitol in a clinical specimen.

Device Sizes#

Type, Value, Unit table
Type	Value	Unit
Device Size Text, specify	0
Device Size Text, specify	0

Storage And Handling#

Type, Low, High table
Type	Low	High	Condition
Storage Environment Temperature	2 Degrees Celsius	8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
Phone	Email
8887440221	info@glycomark.com
8887440221	info@precisiondiabetesinc.com

Regulatory Flags#

DUNS number: 690547468
Device count: 1
Kit: true
Lot or batch: true
Expiration date on label: true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
04987170775579	GLYCOMARK	NK-8320		2016-09-24
04987170775586	GLYCOMARK	NK-8330		2016-09-24

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00817089022539	Diazyme	DIAZYME LABORATORIES, INC.	NOZ	2023-11-29
00817089022584	Diazyme	DIAZYME LABORATORIES, INC.	NOZ	2023-11-29
00817089022744	Diazyme	DIAZYME LABORATORIES, INC.	NOZ	2023-11-29