FDA.reportPublic FDA data

Leica Biosystems CytoVision HD with Image, HP dc78

Primary DI
00849832009924
Brand
Leica Biosystems CytoVision HD with Image, HP dc78
Company
Leica Biosystems Richmond, Inc.
Model
23DKI7810
Device description
Leica Biosystems CytoVision HD with Image, HP dc7800 RAID 1
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
00849832009924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849832009924008498320099248498320099240849832009924

GMDN Terms#

Term, Definition table
TermDefinition
Hard-disc-station computer driveA device designed to be connected to one or more computers in order to provide more hard disc storage capacity.

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
20849832016322Leica Biosystems380008138000812026-10-28
20849832016339Leica Biosystems380008238000822026-10-28
20849832016452Leica Biosystems380008338000832026-10-28
20849832023139Leica Biosystems380008038000802026-10-28
20849832023405Leica Biosystems380008538000852026-10-28
20849832023412Leica Biosystems380008638000862026-10-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350040977194CellaVision® Remote Review Single EditionCellavision ABJOY2026-05-08
07290118610892X100HT SystemSCOPIO LABS LTDJOY2024-12-01
07290016630046ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.JOY2024-07-02
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 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
00849832013204Leica ADAPTOR C14 TO C7, POWER SUPPLYLeica Biosystems Richmond, Inc.JOY2017-10-13