AccessGUDID - DEVICE: GLYCOMARK (04987170775586)

GUDID

Device Identifier (DI) Information

Brand Name: GLYCOMARK
Version or Model: NK-8330
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NIPPON KAYAKU CO., LTD.

Primary DI Number: 04987170775586
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690547468 *Terms of Use

Device Description: Controls 1,5-anhydroglucitol (1,5-AG) Enzymatic 1,5-AG Assay for Glycemic Control

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
1,5-Anhydroglucitol IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of 1,5-anhydroglucitol in a clinical specimen.

FDA Product Code

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Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031604	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3 Vials, 2 Milliliter each (Low Control)
Device Size Text, specify: 3 Vials, 2 Milliliter each (High Control)

Device Record Status

Public Device Record Key: 1877352c-ccf8-40c9-98d2-f4fb94999a37
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016