K-CHECK

Basic Information

• Brand Name: K-CHECK
• Primary DI: 00860009154001
• Version / Model: 1
• Catalog Number: B1555
• Company Name: Biorex Labs LLC
• Labeler DUNS: 060975106
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 1
• Public Version Date: 2022-12-12
• Public Version Status: New
• Public Device Record Key: f071a292-9c7d-49e6-bd67-77f8d698dae2

Device Description

The K-Check tablet is a chromogenic reagent to be used by trained laboratory professionals to determine the qualitative /semi-quantitative presence of two Ketone bodies i.e. acetone and acetoacetic acid in Urine, Serum, Plasma or Whole blood. The test results are read visually.

Device Characteristics

• Single Use: Yes
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	862.1435	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55471	Acetone 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 detection of acetone in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009154001	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius