Lucica® Glycated Albumin-L GA R-2 L222GA

GUDID 04987153301023

GA R-2 Enzymatic solution 10mL x 2

ASAHI KASEI PHARMA CORPORATION

Glycated albumin IVD, reagent

• Primary Device ID: 04987153301023
• NIH Device Record Key: 622de500-2bba-4d5e-9f10-c86b1d50066a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lucica® Glycated Albumin-L GA R-2
• Version Model Number: L222GA
• Catalog Number: L222GA
• Company DUNS: 700853096
• Company Name: ASAHI KASEI PHARMA CORPORATION
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18005315535
• Email: techsupport@ekfdiagnostics.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987153301023 [Primary]

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: 2019-03-11
• Device Publish Date: 2019-02-22

Devices Manufactured by ASAHI KASEI PHARMA CORPORATION

• 04987153301016 - Lucica® Glycated Albumin-L GA R-1: 2019-10-29 GA R-1 Pretreatment solution 40 mL x 2
• 04987153301023 - Lucica® Glycated Albumin-L GA R-2: 2019-03-11GA R-2 Enzymatic solution 10mL x 2
• 04987153301023 - Lucica® Glycated Albumin-L GA R-2: 2019-03-11 GA R-2 Enzymatic solution 10mL x 2
• 04987153301030 - Lucica® Glycated Albumin-L ALB R-1: 2019-03-11 ALB R-1 Pretreatment solution 40 mL x 2
• 04987153301047 - Lucica® Glycated Albumin-L ALB R-2: 2019-03-11 ALB R-2 Coloring solution 20mL x 2
• 04987153301054 - Calibrator for Lucica® Glycated Albumin-L: 2019-03-11 Calibrator L (1 mL × 1), Calibrator H (1 mL × 1)
• 04987153301061 - Control for Lucica® Glycated Albumin-L: 2019-03-11 Control L (3 mL × 1), Control H (3 mL × 1)