DILUENT 80

GUDID 04987486015130

These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. This product dilutes

ARKRAY USA, INC.

Glycated haemoglobin (HbA1c) IVD, reagent

• Primary Device ID: 04987486015130
• NIH Device Record Key: 3ae96077-267c-473c-a06a-661f42d3260a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DILUENT 80
• Version Model Number: 103399
• Company DUNS: 008171162
• Company Name: ARKRAY USA, INC.
• 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: false
• Device Combination Product: false
• Single Use: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Opened: Store in a refrigerator (2-8C)
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987486015130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162822

FDA Product Code

• PDJ: Hemoglobin A1c Test System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-08

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