FDA.reportPublic FDA data

Leica Biosystems CytoVision Olympus 91018 BX2 ET G

Primary DI
00849832006671
Brand
Leica Biosystems CytoVision Olympus 91018 BX2 ET G
Company
Leica Biosystems Richmond, Inc.
Model
231FL5932
Device description
Leica Biosystems CytoVision Olympus 91018 BX2 ET GFP MCH Dual
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOYDEVICE, AUTOMATED CELL-LOCATING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOYDevice, Automated Cell-LocatingHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849832006671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849832006671008498320066718498320066710849832006671

GMDN Terms#

Term, Definition table
TermDefinition
Microscope objectiveA lens or lens group that forms the part of the optical system of a microscope closest to the object. It is used to magnify the viewed image. The objective may be supplied singularly, in pairs, or in sets of increasing magnification.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)5374669tech.support@Leicabiosystems.c

Regulatory Flags#

DUNS number
082930884
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10849832027819Leica Biosystems380320038032002026-05-22
00849832001003Leica Biosystems39LC-700-139LC-700-12025-07-23
00849832001010Leica Biosystems39LC-700-239LC-700-22025-07-23
00849832001027Leica Biosystems39LC-700-339LC-700-32025-07-23
00849832001034Leica Biosystems39LC-700-439LC-700-42025-07-23
00849832001041Leica Biosystems39LC-700-539LC-700-52025-07-23
00849832001058Leica Biosystems39LC-705-439LC-705-42025-07-23
00849832003090Leica Biosystems39LC-705-339LC-705-32025-07-23
00849832025818Leica Biosystems39LC-705-139LC-705-12025-07-23
00849832025825Leica Biosystems39LC-705-239LC-705-22025-07-23
00849832025832Leica Biosystems39LC-705-539LC-705-52025-07-23
00849832023210Leica Biosystems3800200E3800200E2025-07-23
00849832024170Leica Biosystems380037338003732025-07-23
00849832024316Leica Biosystems380038038003802025-07-23
00849832024323Leica Biosystems380037538003752025-07-23
00849832024354Leica Biosystems380022038002202025-07-23
00849832025337Leica Biosystems380024038002402025-07-23
00849832000808Leica Biosystems38VSP5816638VSP581662025-07-20
00849832001317Leica Biosystems380148038014802025-07-20
00849832002567Leica Biosystems380108538010852025-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290118610892X100HT SystemSCOPIO LABS LTDJOY2024-12-01
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07290018417034X100 Digital ScannerSCOPIO LABS LTDJOY2022-12-30
07290018417072X100 Processing Unit (Complete Unit)SCOPIO LABS LTDJOY2022-12-30
07290018417096X100HT Digital Scanner SCOPIO LABS LTDJOY2022-12-30
07290018417126X100HT Processing Unit SCOPIO LABS LTDJOY2022-12-30
07290018417133X100 with Full Field Peripheral Blood Smear ApplicationSCOPIO LABS LTDJOY2022-12-30
07290018417140X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationSCOPIO LABS LTDJOY2022-12-30
07290016630039ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.JOY2022-03-21
07350040975091CellaVision DC-1Cellavision ABJOY2020-10-22
07350040975107CellaVision DC-1 PPACellavision ABJOY2020-10-22
00849832013488WIN10 CPU UPGRADE FOR GSL(IN WARRANTY)Leica Biosystems Richmond, Inc.JOY2019-11-09
00849832013495WIN10CPU UPGRADE FOR CAPTURE(INWARRANTY)Leica Biosystems Richmond, Inc.JOY2019-11-09
07350040974544CellaVision® Remote Review Software, Enterprise upgrade from Group Ed.Cellavision ABJOY2019-02-19
07350040974551CellaVision® Remote Review Software, Enterprise upgrade from Team Ed.Cellavision ABJOY2019-02-19
07350040974575CellaVision® Remote Review Software, Group upgrade from Team Ed.Cellavision ABJOY2019-02-19
07350040975893CellaVision® Remote Review Software, Professional Edition, version independentCellavision ABJOY2019-02-19
07350040975909CellaVision® Remote Review Software, Team Edition, version independentCellavision ABJOY2019-02-19
07350040975916CellaVision® Remote Review Software, Group Edition, version independentCellavision ABJOY2019-02-19
07350040975923CellaVision® Remote Review Software, Enterprise Edition, version independentCellavision ABJOY2019-02-19
07350040975930DI Remote Review Software version 6.x.xCellavision ABJOY2019-02-19
04987562444779Fully Automated Urine Particle Digital Imaging DevSYSMEX CORPORATIONJOY2018-12-11
07350040973745CellaVision® Advanced RBC Application DM1200Cellavision ABJOY2018-03-05
07350040973752CellaVision® Advanced RBC Application DM96Cellavision ABJOY2018-03-05
07350040973769CellaVision® Advanced RBC Application DM9600Cellavision ABJOY2018-03-05
07350040974759For DI Advanced RBC Application Cellavision ABJOY2018-03-05
07290016630015GenASIs™ SystemAPPLIED SPECTRAL IMAGING LTD.JOY2018-01-25
00849832003304Leica Biosystems CytoVision GSL10 scanning sys for Karyotyping&FISHLeica Biosystems Richmond, Inc.JOY2016-11-21
00849832003342Leica Biosystems CytoVision MB8 scanning system for Karyotyping&FISHLeica Biosystems Richmond, Inc.JOY2016-11-14
00849832003649Leica Biosystems CytoVision Karyotyping Software License ActivationLeica Biosystems Richmond, Inc.JOY2016-10-05