ExtendSURE

GUDID 09421902348020

The lyophilised Hemoglobin FASC Control kit contains 4 vials of level 1 control which are prepared as a stabilized hemolysate 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 ID09421902348020
NIH Device Record Key04e3d077-5840-4e57-bde6-4c0fb3d72fa3
Commercial Distribution StatusIn Commercial Distribution
Brand NameExtendSURE
Version Model NumberHB610
Company DUNS590649471
Company NameCANTERBURY SCIENTIFIC LIMITED
Device Count1
DM Exemptfalse
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
GS109421902348020 [Primary]

FDA Product Code

JCMControl, Hemoglobin, Abnormal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-24
Device Publish Date2018-09-20

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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