Nitro-tab Ketone Tablets

Basic Information

• Brand Name: Nitro-tab Ketone Tablets
• Primary DI: 00657498002131
• Version / Model: 4000-100
• Catalog Number: 4000-100
• Company Name: STANBIO LABORATORY, L.P.
• Labeler DUNS: 045361136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2019-03-11
• Public Version: 1
• Public Version Date: 2019-03-19
• Public Version Status: New
• Public Device Record Key: 869b95de-760c-4a27-bc4a-3c8e49af2e8c

Device Description

Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood.

Device Characteristics

• Single Use: Yes
• 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
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	862.1435	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53341	Ketone (acetoacetate) 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 ketone (acetoacetate) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00657498002131	GS1
Unit of Use	00657498002148	GS1

Customer Contacts

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

Storage Conditions

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