Tosoh EU

GUDID 09421902348105

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 are prepared as a stabilized haemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures.

CANTERBURY SCIENTIFIC LIMITED

Multiple haemoglobin subtype IVD, control

• Primary Device ID: 09421902348105
• NIH Device Record Key: 73eb3f3b-4f3d-45d8-9226-50fb45d33579
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tosoh EU
• Version Model Number: 997050
• 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: false
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421902348105 [Primary]

FDA Product Code

• JCM: Control, Hemoglobin, Abnormal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-24
• Device Publish Date: 2018-11-02

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: 2019-07-24 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