FDA.report

Leica Biosystems CytoVision HPdc78/7900 XP to Win

Primary DI
00849832005032
Brand
Leica Biosystems CytoVision HPdc78/7900 XP to Win
Company
Leica Biosystems Richmond, Inc.
Model
23HDUWIN7CV72004
Device description
Leica Biosystems CytoVision HPdc 78/7900 XP to Win 7 HD RAID 1 UG
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

Related Records

Contact Domains

Product Codes

CodeName
JOYDEVICE, AUTOMATED CELL-LOCATING

Product Code Classifications

CodeDeviceSpecialtyClass
JOYDevice, Automated Cell-LocatingHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00849832005032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00849832005032008498320050328498320050320849832005032

GMDN Terms

TermDefinition
Laboratory analyser operation system software IVDMainframe or personal computer (PC) based operating system software (or firmware) that is specific to the central processing unit (CPU) incorporated into an analyser or analyser system. This includes the software or firmware based programs and routines supplied by the computer manufacturer that drive a specific computer in the performance of its tasks and assists the operators, applications programmers and programs with various supporting functions. A proprietary name and a "version number" are commonly used to identify different operating system versions.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods

Method

Contacts

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

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