BD FACSPresto

Primary DI
00382906607461
Brand
BD FACSPresto
Company
Becton, Dickinson And Company
Model
660746
Catalog number
660746
Device description
BD FACSPresto™ CD4/Hb Cartridges
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
00382906607461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382906607461003829066074613829066074610382906607461

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382902780519BD Macro-Vue™ Card Test Rotator2780512780512016-05-19
00885403522324Swan-Ganz151F7151F72026-07-31
00885403523581VAMP48VMP10648VMP1062026-07-31
00885403523598VAMP48VMP12048VMP1202026-07-31
00885403523734VAMP48VMP18448VMP1842026-07-31
00885403524281TruWave, VAMP PlusPXVP1087PXVP10872026-07-31
00885403524694TruWave, VAMP PlusPXVP0550PXVP05502026-07-31
00885403524922TruWavePX266CPX266C2026-07-31
00885403525066TruWave, VAMPPXAVMPPXAVMP2026-07-31
00885403525547TruWave, VAMPPXAVMP3PXAVMP32026-07-31
00885403525608TruWave, VAMPPXVMP172AT3PXVMP172AT32026-07-31
00885403525646TruWave, VAMP PlusPXVP1071PXVP10712026-07-31
00885403529644Acumen IQ CuffAIQCLAIQCL2026-07-31
00885403529651Acumen IQ CuffAIQCMAIQCM2026-07-31
00885403530404Fogarty120404F120404F2026-07-31
00885403530411Fogarty120602F120602F2026-07-31
00885403530428Fogarty120803F120803F2026-07-31
00885403530442Fogarty120804F120804F2026-07-31
00885403530466Fogarty120805F120805F2026-07-31
00885403530565Fogarty12TLW805F3512TLW805F352026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382906607454BD FACSPrestoBecton, Dickinson And CompanyPMG2019-08-20
00382906607478BD FACSPrestoBecton, Dickinson And CompanyPMG2017-08-30