hemochroma PLUS Starter Kit

Basic Information

• Brand Name: hemochroma PLUS Starter Kit
• Primary DI: 10722355003051
• Version / Model: 100-PROMO
• Catalog Number: 100-PROMO
• Company Name: IMMUNOSTICS COMPANY, INC
• Labeler DUNS: 119214195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-12-20
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: acefab10-66ff-4fc6-89f5-5b6d1300d575

Device Description

1 hemochroma PLUS Analyzer+100 Microcuvettes+1 optical system check

Device Characteristics

• Single Use: Yes
• 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
55872	Total haemoglobin (totHb) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total haemoglobin (totHb) in a clinical specimen, using a spectrophotometry method.	No	Active
55875	Total haemoglobin (totHb) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of total haemoglobin (totHb) in a clinical specimen.	No	Active
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	10722355003051	GS1
Unit of Use	80722355003050	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: High: 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 15 – 35 Degrees Celsius