Primary Device ID | 09421902348020 |
NIH Device Record Key | 04e3d077-5840-4e57-bde6-4c0fb3d72fa3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ExtendSURE |
Version Model Number | HB610 |
Company DUNS | 590649471 |
Company Name | CANTERBURY SCIENTIFIC LIMITED |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 09421902348020 [Primary] |
JCM | Control, Hemoglobin, Abnormal |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-07-24 |
Device Publish Date | 2018-09-20 |
09421902348099 | The liquid Hemoglobin A1c Control kit contains 12 vials each of level 1 and level 2 controls whi |
09421902348082 | The lypholised Hemoglobin A1c Linearity kit contains 1 vial each of level 1, 2, 3, 4 and 5 contr |
09421902348075 | The lypholised Hemoglobin A1c Control kit contains 4 vials each of level 1 and level 2 controls |
09421902348044 | The lyophilised Hemoglobin F and A2 with HbS in level 2 Calibrator kit contains 2 vials each of |
09421902348037 | The lyophilised Hemoglobin F and A2 with HbS in level 2 Control kit contains 4 vials each of lev |
09421902348020 | The lyophilised Hemoglobin FASC Control kit contains 4 vials of level 1 control which are prepar |
09421902348006 | The liquid Hemoglobin A1c Control kit contains 2 vials each of level 1 and level 2 controls whic |
09421902348112 | The lypholised Hemoglobin A1c Linearity controls are prepared from human blood and contain norma |