FDA.reportPublic FDA data

Leica Biosystems CytoVision Leica DM Cube Spectrum

Primary DI
00849832004738
Brand
Leica Biosystems CytoVision Leica DM Cube Spectrum
Company
Leica Biosystems Richmond, Inc.
Model
23FLRET4930672
Device description
Leica Biosystems CytoVision Leica DM Cube Spectrum Red
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
00849832004738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849832004738008498320047388498320047380849832004738

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
00849832004066Leica Biosystems CytoVision DM5500 for FL-Ergo Head23MIC550FXX0092016-09-17
00849832007920Leica Biosystems Ariol Fluorescent Unit23AXCITEDM2016-09-17
00849832007937Leica Biosystems Ariol UPS 110V23UPS22072016-09-17
00849832007944Leica Biosystems Ariol UPS 220V23UPS22082016-09-17
00849832009504Leica Biosystems Ariol MSCOPE Leica DM6000B BZ03 Ariol Multibay23MIC60042016-09-17
00849832009511Leica Biosystems Ariol Leica DM6000B Ariol23MIC60052016-09-17
00849832010333Leica Biosystems Ariol DM6000 B Basic Configuration Ariol23MIC12012016-09-17
00849832010340Leica Biosystems Ariol DM6000 B Basic Configuration Ariol Refurbished23MIC1201R2016-09-17
00849832010418Leica Biosystems Ariol DM6000 B Ariol PL20023MIC12062016-09-17
00849832010425Leica Biosystems Ariol DM6000 B for Ariol PL200 Refurbished23MIC1206R2016-09-17
00849832011361Leica Biosystems Ariol Beveled Edge Slide Holder23ASLSP0162016-12-02
00849832011576Leica Biosystems Ariol Cable, stage sensor23ASLSP0302017-03-29
00849832013204Leica ADAPTOR C14 TO C7, POWER SUPPLY23ADP00022017-10-13
00849832013228Leica Biosystems Slide Cassettes, SL20023ASLSP0032017-11-17
20849832020978Leica Biosystems39LC-675-10-50039LC-675-10-5002025-04-15
20849832022194Leica Biosystems38440305384403052025-04-16
00849832028451Leica Biosystems380365838036582026-10-21
10849832028465Leica Biosystems380173438017342026-10-21
10849832028472Leica Biosystems380015338001532026-10-21
00849832028345Leica Biosystems380365538036552026-10-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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 Device UD-10SYSMEX 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
00849832013228Leica Biosystems Slide Cassettes, SL200Leica Biosystems Richmond, Inc.JOY2017-11-17
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