Whole Blood Calibration Standard

Basic Information

• Brand Name: Whole Blood Calibration Standard
• Primary DI: 04250317544070
• Version / Model: 66003
• Catalog Number: 66003
• Company Name: Chromsystems Instruments + Chemicals GmbH
• Labeler DUNS: 328712260
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-10
• Public Version: 1
• Public Version Date: 2019-09-18
• Public Version Status: New
• Public Device Record Key: a4214a7a-9739-4416-b077-086651dc462b

Device Description

Whole Blood Calibration Standard Glutathione

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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
JIT	Calibrator, Secondary	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64375	Glutathione IVD, kit, liquid chromatography	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glutathione in the reduced form (GSH) or oxidase form (GSSG), in a clinical specimen, using a liquid chromatography method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250317544070	GS1
Package	04250317514035	GS1		5	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			5 x 0.5 ml

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – -18 Degrees Celsius