Hemo-QC

Basic Information

• Brand Name: Hemo-QC
• Primary DI: 00858352006009
• Version / Model: H9200
• Catalog Number: H9200
• Company Name: HEMO BIOSCIENCE INC
• Labeler DUNS: 143647035
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-20
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 72b83b54-52d3-4141-a154-14c48d92c92d

Device Description

Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, semi-automated and automated blood typing and antibody screen test systems.

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
60727	Multiple blood group genotyping IVD, control	A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to determine the genotype for one or multiple blood groups. The blood group systems to be genotyped may include Rhesus (CcDEe), Kell (K, k, Kp^a, Kp^b), Duffy (Fy^a, Fy^b, Fy^x), Kidd (Jk^a, Jk^b), Lewis (Le^a, Le^b), MNS (M, N, S, s, U), Xg (Xg^a), Dombrock (Do^a, Do^b), Colton (Co^a, Co^b), Cartwright (Yt^a, Yt^b), Lutheran (Lu^a, Lu^b) and/or Diego (Di^a, Di^b).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858352006009	GS1

Customer Contacts

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

Storage Conditions

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