tosoh.comEXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS
CANTERBURY SCIENTIFIC LTD.
CANTERBURY SCIENTIFIC LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003982601 | 3003982601 | CANTERBURY SCIENTIFIC LTD. | 1 | N | 2026-01-01 | 71 Whiteleigh Avenue Addington Christchurch Canterbury NZ 8011 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 09421902348068 | TOSOH - Hemoglobin A1c Controls Levels 1 and 2, 4 vials of Level 1 Controls (0.25mL reconstituted), 4 Vials of Level 2 Controls (0.25mL reconstituted), 1 Package Insert | +0016506368136 | carla.terry@tosoh.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 20847 | 1594539153 | K071648 | EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS | JJX | 2007-08-22 |
| 20847 | 1704362826 | K053031 | EXTENDSURE HBFASC CONTROL | JCM | 2005-12-07 |
| 20847 | 1701667568 | K043070 | LIQUID STABLE HBA1C CONTROL | JJX | 2004-12-09 |
| 20847 | 1945127508 | K011389 | HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) | JCM | 2001-06-21 |
| 20847 | 1280434952 | ||||
| 20847 | 1932654435 |
Product Codes Associated With Registrations#
PMN#
LIQUID STABLE HBA1C CONTROL
CANTERBURY SCIENTIFIC LTD.
HEMOGLOBIN A1C CONTROL
CANTERBURY SCIENTIFIC LTD.
GUDID#
ExtendSure - 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.
2020-10-12
ExtendSURE - The liquid Hemoglobin A1c Control kit contains 2 vials each of level 1 and level 2 controls 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.
2018-09-20
ExtendSURE - 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.
2018-09-20
ExtendSURE - The lyophilised Hemoglobin F and A2 with HbS in level 2 Control kit contains 4 vials each of level 1 and level 2 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.
2018-09-20
ExtendSURE - The lyophilised Hemoglobin F and A2 with HbS in level 2 Calibrator kit contains 2 vials each of level 1 and level 2 calibrator which are prepared as a stabilized hemolysate from human blood. The calibrators are designed to establish known points of reference in laboratory testing procedures.
2018-09-20
Tosoh US - The lyophilised Hemoglobin F and A2 with S in level 2 Control kit contains 4 vials each of level 1 and level 2 control which are prepared as a stabilized haemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures.
2018-11-02
TOSOH - Hemoglobin A1c Controls Levels 1 and 2, 4 vials of Level 1 Controls (0.25mL reconstituted), 4 Vials of Level 2 Controls (0.25mL reconstituted), 1 Package Insert
2016-10-24
ExtendSURE - The lypholised Hemoglobin A1c Control kit contains 4 vials each of level 1 and level 2 controls 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.
2018-09-20
ExtendSURE - The lypholised Hemoglobin A1c Linearity kit contains 1 vial each of level 1, 2, 3, 4 and 5 controls 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.
2018-09-20
ExtendSURE - The liquid Hemoglobin A1c Control kit contains 12 vials each of level 1 and level 2 controls 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.
2018-09-20
Tosoh EU - The lyophilised Hemoglobin F and A2 with S in level 2 Control kit contains 4 vials each of level 1 and level 2 control which are prepared as a stabilized haemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures.
2018-11-02