MQC-CAT

Basic Information

• Brand Name: MQC-CAT
• Primary DI: 00858352006139
• Version / Model: H9350
• Company Name: HEMO BIOSCIENCE INC
• Labeler DUNS: 143647035
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-26
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 3212a7ef-a5f4-4563-ac2c-0db5d51ac962

Device Description

MQC-CAT is intended for the quality control of routine blood bank reagents when tested by CAT techiques.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	864.9650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55864	Non-blood cell primer/calibrator/control material IVD, reagent	A substance or reactant intended to be used as a non-blood cell primer, calibrator and/or control to prepare or establish the operational performance of an instrument prior to its use in routine haematological analysis of a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858352006139	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

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