Pointe Scientific, Inc.

Basic Information

• Brand Name: Pointe Scientific, Inc.
• Primary DI: 00811727014566
• Version / Model: H7546-CTL
• Catalog Number: H7546-CTL
• Company Name: POINTE SCIENTIFIC, INC.
• Labeler DUNS: 045623154
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4c50ab10-349b-4abf-9802-1476b8cfb23d

Device Description

Liquid Hemoglobin A1c Control Set, The HbA1c controls are reference controls consisting of human blood based solutions. It is intended to simulate human patient whole blood samples for the purpose of monitoring the precision of laboratory testing procedures for the following assays: HbA1c. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. Size: 4 x 0.5 mL

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
JPK	Mixture, Hematology Quality Control	Hematology	864.8625	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44435	Glycated haemoglobin (HbA1c) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811727014566	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K952720	000

Storage Conditions

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