FDA.reportPublic FDA data

Reticcount

Primary DI
00382903492046
Brand
Reticcount
Company
Becton, Dickinson And Company
Model
349204
Catalog number
349204
Device description
Retic-Count Reticulocyte Rgnt System IVD
Published
2016-06-08
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
GKLCOUNTER, CELL, AUTOMATED (PARTICLE COUNTER)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKLCounter, Cell, Automated (Particle Counter)Hematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382903492046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382903492046003829034920463829034920460382903492046

GMDN Terms#

Term, Definition table
TermDefinition
Multiple CD cell marker IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in the dark
Storage Environment Temperature2 Degrees Celsius8 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
00382905167065BD Intelliport5167065167062020-09-30
50382905167015BD Intelliport5167015167012020-09-30
00382905167508BD Intelliport5167505167502020-09-30
00382905168031BD Intelliport System5168035168032024-06-07
00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00630414222899ADVIA 120/2120/2120i® DIFF TIMEpacSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222905ADVIA 120/2120/2120i® autoRETICSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222912ADVIA 120/2120/2120i® AUTOreticSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222929ADVIA 120/2120/2120i® Sheath/RinseSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222943ADVIA 120/2120/2120i® DefoamerSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414222950ADVIA 120/2120/2120i® CN-FREE CBC TIMEPACSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414223032ADVIA 120/2120/2120i® Sheath/RinseSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414224305ADVIA 120/2120/2120i® OPTIpointSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414224329ADVIA 120/2120/2120i® OPTIpointSiemens Healthcare Diagnostics Inc.GKL2016-09-24
00630414473383ADVIA 120/2120/2120i® Perox SheathSiemens Healthcare Diagnostics Inc.GKL2016-09-24
10816068020174Advanced Instruments Glocyte® Tips, 10 Pks of 96, 1-200uL PolypropyleneAdvanced Instruments, LLCGKL2016-09-23
10816068020211Advanced Instruments GloCyte® Red Blood Cell Test Reagent KitAdvanced Instruments, LLCGKL2016-09-23
10816068020228Advanced Instruments GloCyte® Total Nucleated Cell Test Reagent KitAdvanced Instruments, LLCGKL2016-09-23
10816068020204Advanced Instruments GloCyte® Test Cartridge & Tray - 25 CartridgesAdvanced Instruments, LLCGKL2016-09-23
15099590233754COULTER Latron CP-XBeckman Coulter, Inc.GKL2016-09-23
15099590250683COULTER LatronBeckman Coulter, Inc.GKL2016-09-23
15099590250690COULTER Latron Beckman Coulter, Inc.GKL2016-09-23
20816068020201Advanced Instruments GloCyte® Test Cartridge Kit - 8 TraysAdvanced Instruments, LLCGKL2016-09-23
00816068020009Advanced Instruments GloCyte® Pipette, 30µL Fixed VolumeAdvanced Instruments, LLCGKL2016-09-23
00816068020016Advanced Instruments GloCyte® Pipette, 10µL Fixed VolumeAdvanced Instruments, LLCGKL2016-09-23
00816068020139Advanced Instruments GloCyte® Automated Cell Counter SystemAdvanced Instruments, LLCGKL2016-09-23
00816068020146Advanced Instruments GloCyte® Instrument AssemblyAdvanced Instruments, LLCGKL2016-09-23
00816068020153Advanced Instruments GloCyte® Vacuum Preparation Station AssemblyAdvanced Instruments, LLCGKL2016-09-23
00816068020245Advanced Instruments GloCyte® Count Template CartridgeAdvanced Instruments, LLCGKL2016-09-23
10837461002475iQ®200 BECKMAN COULTER IRELAND INC.GKL2016-09-07
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