CANTERBURY SCIENTIFIC LIMITED

Address:71 Whiteleigh Avenue,Christchurch Canterbury,NZ

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Control, Hemoglobin, Abnormal (JCM) (5) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (5)

Premarket Exempt

Yes

Clear

ExtendSURE - 09421902348006 Catalog Number :

Device Description : The liquid Hemoglobin A1c Control kit contains 2 vials each of level 1 and level

Device Class : 1

Duns Number: 590649471

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

ExtendSURE - 09421902348020 Catalog Number :

Device Description : The lyophilised Hemoglobin FASC Control kit contains 4 vials of level 1 control

Device Class : 2

Duns Number: 590649471

Premarket Exempt : Yes

Product Code : JCM

Prescription Use : No

Device Count : 1

ExtendSURE - 09421902348037 Catalog Number :

Device Description : The lyophilised Hemoglobin F and A2 with HbS in level 2 Control kit contains 4 v

Device Class : 2

Duns Number: 590649471

Premarket Exempt : Yes

Product Code : JCM

Prescription Use : No

Device Count : 1

ExtendSURE - 09421902348044 Catalog Number :

Device Description : The lyophilised Hemoglobin F and A2 with HbS in level 2 Calibrator kit contains

Device Class : 2

Duns Number: 590649471

Premarket Exempt : Yes

Product Code : JCM

Prescription Use : No

Device Count : 1

Tosoh US - 09421902348051 Catalog Number :

Device Description : The lyophilised Hemoglobin F and A2 with S in level 2 Control kit contains 4 via

Device Class : 2

Duns Number: 590649471

Premarket Exempt : Yes

Product Code : JCM

Prescription Use : Yes

Device Count : 1

TOSOH - 09421902348068 Catalog Number :

Device Description : Hemoglobin A1c Controls Levels 1 and 2, 4 vials of Level 1 Controls (0.25mL reco

Device Class : 1

Duns Number: 590649471

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

ExtendSURE - 09421902348075 Catalog Number :

Device Description : The lypholised Hemoglobin A1c Control kit contains 4 vials each of level 1 and l

Device Class : 1

Duns Number: 590649471

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

ExtendSURE - 09421902348082 Catalog Number :

Device Description : The lypholised Hemoglobin A1c Linearity kit contains 1 vial each of level 1, 2,

Device Class : 1

Duns Number: 590649471

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

ExtendSURE - 09421902348099 Catalog Number :

Device Description : The liquid Hemoglobin A1c Control kit contains 12 vials each of level 1 and leve

Device Class : 1

Duns Number: 590649471

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

Tosoh EU - 09421902348105 Catalog Number :

Device Description : The lyophilised Hemoglobin F and A2 with S in level 2 Control kit contains 4 via

Device Class : 2

Duns Number: 590649471

Premarket Exempt : Yes

Product Code : JCM

Prescription Use : Yes

Device Count : 1

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