KETO-DIASTIX®

Basic Information

• Brand Name: KETO-DIASTIX®
• Primary DI: 10301932882212
• Version / Model: 2882
• Catalog Number: 2882
• Company Name: ASCENSIA DIABETES CARE US INC.
• Labeler DUNS: 080028910
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2019-06-06
• Public Version: 4
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: ce917f84-59d3-48a7-9905-874b115c06cc

Device Description

Reagent Strips for Urinalysis: Ketone; Glucose

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	862.1340	2
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	862.1435	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54514	Multiple urine analyte IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40301932882213	GS1	shipper/case	12	In Commercial Distribution
Package	00301932882215	GS1	carton	1	In Commercial Distribution
Primary	10301932882212	GS1
Secondary	0193-2882-21	NDC/NHRIC
Unit of Use	00301932882017	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Read enclosed directions carefully. Use within 6 mos after first open. Tamper evident seal.
• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit