Direct A1c Calibrator Kit 55120

GUDID 03661540304293

Calibrator intended to establish known points of reference for use with Direct A1c Reagent Kit 55370.

ELITECHGROUP INC.

Glycated haemoglobin (HbA1c) IVD, calibrator

• Primary Device ID: 03661540304293
• NIH Device Record Key: a29ecf75-0698-43aa-8577-3c2a36d383df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Direct A1c Calibrator Kit
• Version Model Number: 55120
• Catalog Number: 55120
• Company DUNS: 052423787
• Company Name: ELITECHGROUP 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540304293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031539

FDA Product Code

• LCP: Assay, Glycosylated Hemoglobin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-09
• Device Publish Date: 2023-10-01

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