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 ID09421902348112
NIH Device Record Keya97eb994-4c06-49b4-bb5b-24fb8129361e
Commercial Distribution StatusIn Commercial Distribution
Brand NameExtendSure
Version Model Number107253
Catalog NumberHB510Ar
Company DUNS590649471
Company NameCANTERBURY SCIENTIFIC LIMITED
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109421902348112 [Primary]

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-20
Device Publish Date2020-10-12

On-Brand Devices [ExtendSure]

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

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