β-Hydroxybutyrate 21 Bi-Level Controls

Basic Information

• Brand Name: β-Hydroxybutyrate 21 Bi-Level Controls
• Primary DI: 04051839002921
• Version / Model: 595409943084
• Catalog Number: 595409943084
• Company Name: DiaSys Diagnostic Systems GmbH
• Labeler DUNS: 328419718
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-15
• Public Version: 1
• Public Version Date: 2018-12-17
• Public Version Status: New
• Public Device Record Key: b6ace5fa-9e0d-4126-b955-cbb9203ac214

Device Description

For use as controls in quantative procedures for β-Hydroxybutyrate

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53333	Beta-hydroxybutyrate IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of beta-hydroxybutyrate (3-hydroxybutyric acid) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04051839002921	GS1

Storage Conditions

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