HbA1c Diluting Solution

GUDID 04562185400571

TOSOH CORPORATION

Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography

• Primary Device ID: 04562185400571
• NIH Device Record Key: 2f664a57-11da-45f6-a903-d881d34e7e93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HbA1c Diluting Solution
• Version Model Number: N/A
• Company DUNS: 690571724
• Company Name: TOSOH 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com
• Phone: 615-806-4671
• Email: Isabelle.Lang-Zwosta@tosoh.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04562185400571 [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: 2026-01-13
• Device Publish Date: 2026-01-05

Devices Manufactured by TOSOH CORPORATION

• 04560189283923 - Hemoglobin A1c Control Set: 2026-01-13
• 04562185400571 - HbA1c Diluting Solution: 2026-01-13
• 04562185400571 - HbA1c Diluting Solution: 2026-01-13
• 04562185403060 - HbA1c Calibrator Set (S): 2026-01-13
• 04562185404920 - Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01: 2026-01-13
• 04562185404937 - 90 Sample Loader: 2026-01-13
• 04562185404944 - 290 Sample Loader: 2026-01-13
• 04562185405255 - TSKgel GR01 HbA1c Column: 2026-01-13
• 14562185405269 - GR01 HbA1c Elution Buffer No. 1: 2026-01-13