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
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30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30
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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