Tosoh US

GUDID 09421902348051

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.

CANTERBURY SCIENTIFIC LIMITED

Multiple haemoglobin subtype IVD, control
Primary Device ID09421902348051
NIH Device Record Key5455734d-f787-4e60-8c35-317705118df3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTosoh US
Version Model Number997050
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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109421902348051 [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 Date2018-11-02

Devices Manufactured by CANTERBURY SCIENTIFIC LIMITED

09421902348112 - ExtendSure2020-10-20 The lypholised Hemoglobin A1c Linearity controls are prepared from human blood and contain normal hemoglobin, preservatives and
09421902348006 - ExtendSURE2019-07-24 The liquid Hemoglobin A1c Control kit contains 2 vials each of level 1 and level 2 controls which are prepared as a stabilized h
09421902348020 - ExtendSURE2019-07-24 The lyophilised Hemoglobin FASC Control kit contains 4 vials of level 1 control which are prepared as a stabilized hemolysate fr
09421902348037 - ExtendSURE2019-07-24 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
09421902348044 - ExtendSURE2019-07-24 The lyophilised Hemoglobin F and A2 with HbS in level 2 Calibrator kit contains 2 vials each of level 1 and level 2 calibrator
09421902348051 - Tosoh US2019-07-24The 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.
09421902348051 - Tosoh US2019-07-24 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 ar
09421902348068 - TOSOH2019-07-24 Hemoglobin A1c Controls Levels 1 and 2, 4 vials of Level 1 Controls (0.25mL reconstituted), 4 Vials of Level 2 Controls (0.25mL
09421902348075 - ExtendSURE2019-07-24 The lypholised Hemoglobin A1c Control kit contains 4 vials each of level 1 and level 2 controls which are prepared as a stabiliz

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.