BD FACSPresto

Primary DI
00382906607454
Brand
BD FACSPresto
Company
Becton, Dickinson And Company
Model
660745
Catalog number
660745
Device description
BD FACSPresto™ System
Published
2019-08-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMGAutomated multicolor fluorescent imaging cytometric analysis system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMGAutomated Multicolor Fluorescent Imaging Cytometric Analysis SystemHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150815000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150815000BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge KitBecton, Dickinson and Company2015-12-17PMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382906607454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382906607454003829066074543829066074540382906607454

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-careA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)232-8995BDBCustomerService@bd.com

Regulatory Flags#

DUNS number
119218200
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24
00382906718242Horizon6718246718242026-09-24
00382906718259Horizon6718256718252026-09-24
00382906718266Horizon6718266718262026-09-24
00382906718273Horizon6718276718272026-09-24
00382906718280Horizon6718286718282026-09-24
00382906718310Horizon6718316718312026-09-24
00382906718327Horizon6718326718322026-09-24
00382906718334Horizon6718336718332026-09-24
00382906718341Horizon6718346718342026-09-24
00382906718358Not Applicable6718356718352026-09-24
00382906718365Horizon6718366718362026-09-24
00382906718372Horizon6718376718372026-09-24
00382906718389Horizon6718386718382026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382906607461BD FACSPrestoBecton, Dickinson And CompanyPMG2017-08-30
00382906607478BD FACSPrestoBecton, Dickinson And CompanyPMG2017-08-30