BD FACSPresto

Primary DI
00382906607478
Brand
BD FACSPresto
Company
Becton, Dickinson And Company
Model
660747
Catalog number
660747
Device description
BD FACSPresto™ CD4/Hb Cartridges Kit
Published
2017-08-30
Public version status
Update
Distribution status
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
00382906607478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382906607478003829066074783829066074780382906607478

GMDN Terms#

Term, Definition table
TermDefinition
CD4 cell marker IVD, kit, fluorescent immunoassay, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of CD4 cell marker in a clinical specimen within a short period, relative to standard laboratory testing procedures using a fluorescent immunoassay method. This test is commonly used in the laboratory or in point-of-care analysis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius31 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
119218200
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00382904003821BD Whitacre Spinal4003824003822023-09-02
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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
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382906607454BD FACSPrestoBecton, Dickinson And CompanyPMG2019-08-20
00382906607461BD FACSPrestoBecton, Dickinson And CompanyPMG2017-08-30