ExtendSURE

Basic Information

• Brand Name: ExtendSURE
• Primary DI: 09421902348044
• Version / Model: HB110SCALAr
• Company Name: CANTERBURY SCIENTIFIC LIMITED
• Labeler DUNS: 590649471
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-20
• Public Version: 2
• Public Version Date: 2019-07-24
• Public Version Status: Update
• Public Device Record Key: 5dad4b95-d487-45f1-a084-39b4443a3535

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JCM	Control, Hemoglobin, Abnormal	Hematology	864.7415	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55877	Multiple haemoglobin subtype IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or multiple subtypes of haemoglobin in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09421902348044	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius