CANTERBURY SCIENTIFIC LIMITED

Address:71 Whiteleigh Avenue,Christchurch Canterbury,NZ

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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

Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

Yes

Clear

ExtendSure - 09421902348112 Catalog Number : HB510Ar

Device Description : The lypholised Hemoglobin A1c Linearity controls are prepared from human blood a 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.

Device Class : 1

Duns Number: 590649471

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

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