ADAMS™ A1c HA-8180V (UL) Analyzer

GUDID 04987486001973

The ADAMS A1c HA-8180V system is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood and hem

ARKRAY USA, INC.

Glycated haemoglobin (HbA1C) analyser IVD

• Primary Device ID: 04987486001973
• NIH Device Record Key: 00602fc8-38be-4e12-baa6-9be35677325c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADAMS™ A1c HA-8180V (UL) Analyzer
• Version Model Number: 100675
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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 *Environment during transit (1-60 Degrees Celsius and 20-80% RH)
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987486001973 [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: 2017-12-08

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