TOSOH

GUDID 09421902348068

Hemoglobin A1c Controls Levels 1 and 2, 4 vials of Level 1 Controls (0.25mL reconstituted), 4 Vials of Level 2 Controls (0.25mL reconstituted), 1 Package Insert

CANTERBURY SCIENTIFIC LIMITED

Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography

• Primary Device ID: 09421902348068
• NIH Device Record Key: a3f9d870-dff4-4ff4-b876-08affc5dca30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOSOH
• Version Model Number: 220232
• Company DUNS: 590649471
• Company Name: CANTERBURY SCIENTIFIC LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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: +0016506368136
• Email: carla.terry@tosoh.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421902348068 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-24
• Device Publish Date: 2016-10-24

Devices Manufactured by CANTERBURY SCIENTIFIC LIMITED

• 09421902348112 - ExtendSure: 2020-10-20 The lypholised Hemoglobin A1c Linearity controls are prepared from human blood and contain normal hemoglobin, preservatives and
• 09421902348006 - ExtendSURE: 2019-07-24 The liquid Hemoglobin A1c Control kit contains 2 vials each of level 1 and level 2 controls which are prepared as a stabilized h
• 09421902348020 - ExtendSURE: 2019-07-24 The lyophilised Hemoglobin FASC Control kit contains 4 vials of level 1 control which are prepared as a stabilized hemolysate fr
• 09421902348037 - ExtendSURE: 2019-07-24 The lyophilised Hemoglobin F and A2 with HbS in level 2 Control kit contains 4 vials each of level 1 and level 2 control which
• 09421902348044 - ExtendSURE: 2019-07-24 The lyophilised Hemoglobin F and A2 with HbS in level 2 Calibrator kit contains 2 vials each of level 1 and level 2 calibrator
• 09421902348051 - Tosoh US: 2019-07-24 The lyophilised Hemoglobin F and A2 with S in level 2 Control kit contains 4 vials each of level 1 and level 2 control which ar
• 09421902348068 - TOSOH: 2019-07-24Hemoglobin A1c Controls Levels 1 and 2, 4 vials of Level 1 Controls (0.25mL reconstituted), 4 Vials of Level 2 Controls (0.25mL reconstituted), 1 Package Insert
• 09421902348068 - TOSOH: 2019-07-24 Hemoglobin A1c Controls Levels 1 and 2, 4 vials of Level 1 Controls (0.25mL reconstituted), 4 Vials of Level 2 Controls (0.25mL
• 09421902348075 - ExtendSURE: 2019-07-24 The lypholised Hemoglobin A1c Control kit contains 4 vials each of level 1 and level 2 controls which are prepared as a stabiliz