BD Viper™ LT System SDA Accessory Kit

Basic Information

• Brand Name: BD Viper™ LT System SDA Accessory Kit
• Primary DI: 00382904429584
• Version / Model: 442958
• Catalog Number: 442958
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-19
• Public Version: 5
• Public Version Date: 2024-02-21
• Public Version Status: Update
• Public Device Record Key: ba8e3a32-cfa4-4602-bf2b-5e8575a61af4

Device Description

Kit Accessory SDA Viper LT

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
OOI	real time Nucleic acid amplification system	Clinical Chemistry	862.2570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56705	Fluorescent immunoassay analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382904429584	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K140447	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room Temperature