ExtendSure HB510Ar

GUDID 09421902348112

The lypholised Hemoglobin A1c Linearity controls are prepared from human blood and contain normal hemoglobin, preservatives and stabilizers. The controls are formulated to give enhanced stability. The Lyophilized Hemoglobin A1c Linearity Controls are intended to verify the linearity of HbA1c assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols setup within individual clinical laboratories.

CANTERBURY SCIENTIFIC LIMITED

Glucose/haemoglobin (Hb) IVD, control

• Primary Device ID: 09421902348112
• NIH Device Record Key: a97eb994-4c06-49b4-bb5b-24fb8129361e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExtendSure
• Version Model Number: 107253
• Catalog Number: HB510Ar
• Company DUNS: 590649471
• Company Name: CANTERBURY SCIENTIFIC LIMITED
• Device Count: 1
• DM Exempt: true
• 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: false
• 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	09421902348112 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-20
• Device Publish Date: 2020-10-12

On-Brand Devices [ExtendSure]

• 09421902348099: The liquid Hemoglobin A1c Control kit contains 12 vials each of level 1 and level 2 controls whi
• 09421902348082: The lypholised Hemoglobin A1c Linearity kit contains 1 vial each of level 1, 2, 3, 4 and 5 contr
• 09421902348075: The lypholised Hemoglobin A1c Control kit contains 4 vials each of level 1 and level 2 controls
• 09421902348044: The lyophilised Hemoglobin F and A2 with HbS in level 2 Calibrator kit contains 2 vials each of
• 09421902348037: The lyophilised Hemoglobin F and A2 with HbS in level 2 Control kit contains 4 vials each of lev
• 09421902348020: The lyophilised Hemoglobin FASC Control kit contains 4 vials of level 1 control which are prepar
• 09421902348006: The liquid Hemoglobin A1c Control kit contains 2 vials each of level 1 and level 2 controls whic
• 09421902348112: The lypholised Hemoglobin A1c Linearity controls are prepared from human blood and contain norma