STAT-Site B-HB Controls

Basic Information

• Brand Name: STAT-Site B-HB Controls
• Primary DI: 00657498000106
• Version / Model: 303000
• Catalog Number: 303000
• Company Name: STANBIO LABORATORY, L.P.
• Labeler DUNS: 045361136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-04-16
• Public Version Status: Update
• Public Device Record Key: 03b9b479-16f2-4afd-867a-2a0359b94115

Device Description

STAT-Site® Controls are intended to be used to verify the procedural reliability of the assay for β-hydroxybutyrate using STAT-Site® Mβ-HB Meter and Test Strips.

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
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	00657498000106	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 0 Degrees Celsius