hemochroma PLUS Optical System Check

Basic Information

• Brand Name: hemochroma PLUS Optical System Check
• Primary DI: 10722355003044
• Version / Model: 100-404
• Catalog Number: 100-404
• Company Name: IMMUNOSTICS COMPANY, INC
• Labeler DUNS: 119214195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-20
• Public Version: 1
• Public Version Date: 2019-01-21
• Public Version Status: New
• Public Device Record Key: 6f069f11-af00-4221-a62c-fb47d9425410

Device Description

hemochroma PLUS Optical System Check is intended to assure the performance of the optic system of the hemochroma PLUS Analyzer.

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
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED	Hematology	864.5620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55874	Total haemoglobin (totHb) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of total haemoglobin (totHb) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10722355003044	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 35 Degrees Celsius