GLYCOMARK

GUDID 04987170775579

Calibration Standard 1,5-anhydroglucitol (1,5-AG) Enzymatic 1,5-AG Assay for Glycemic Control

NIPPON KAYAKU CO., LTD.

1,5-Anhydroglucitol IVD, calibrator

• Primary Device ID: 04987170775579
• NIH Device Record Key: afcf056e-c89b-4bdf-9669-118b6a063287
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLYCOMARK
• Version Model Number: NK-8320
• Company DUNS: 690547468
• Company Name: NIPPON KAYAKU CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8887440221
• Email: info@glycomark.com
• Phone: 8887440221
• Email: info@precisiondiabetesinc.com
• Phone: 8887440221
• Email: info@precisiondiabetesinc.com
• Phone: 8887440221
• Email: info@precisiondiabetesinc.com
• Phone: 8887440221
• Email: info@precisiondiabetesinc.com
• Phone: 8887440221
• Email: info@precisiondiabetesinc.com
• Phone: 8887440221
• Email: info@precisiondiabetesinc.com
• Phone: 8887440221
• Email: info@precisiondiabetesinc.com
• Phone: 8887440221
• Email: info@precisiondiabetesinc.com
• Phone: 8887440221
• Email: info@precisiondiabetesinc.com
• Phone: 8887440221
• Email: info@precisiondiabetesinc.com
• Phone: 8887440221
• Email: info@precisiondiabetesinc.com
• Phone: 8887440221
• Email: info@precisiondiabetesinc.com
• Phone: 8887440221
• Email: info@precisiondiabetesinc.com
• Phone: 8887440221
• Email: info@precisiondiabetesinc.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987170775579 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031604

FDA Product Code

• JIS: Calibrator, Primary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-09-24

On-Brand Devices [GLYCOMARK]

• 04987170775586: Controls 1,5-anhydroglucitol (1,5-AG) Enzymatic 1,5-AG Assay for Glycemic Control
• 04987170775579: Calibration Standard 1,5-anhydroglucitol (1,5-AG) Enzymatic 1,5-AG Assay for Glycemic Control
• 04987170775562: Kit Reagents 1,5-anhydroglucitol (1,5-AG) Enzymatic 1,5-AG Assay for Glycemic Control