BD FACSPresto

Basic Information

• Brand Name: BD FACSPresto
• Primary DI: 00382906607454
• Version / Model: 660745
• Catalog Number: 660745
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 024230633
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-20
• Public Version: 3
• Public Version Date: 2023-09-01
• Public Version Status: Update
• Public Device Record Key: c74f9b7e-d3c7-4737-993d-25665f3b098b

Device Description

BD FACSPresto™ System

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
PMG	Automated multicolor fluorescent imaging cytometric analysis system	Hematology	864.5220	2
GKL	COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)	Hematology	864.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61039	Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care	A portable, electrically-powered point-of-care instrument typically used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card) after exposure to a clinical specimen, to provide a quantitative and/or qualitative in vitro determination of cells and/or markers, chemical substances and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from the immunological reaction between the reagents and the specimen and uses a spectrophotometric method to measure the absorbance of chemical and/or biological markers. It is mostly used for rapid in vitro diagnostic measurements at the point-of-care or in the laboratory.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382906607454	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150815	000

Storage Conditions

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