FDA.report

Leica CytoVision Workgroup Data Store 1TB RAID1 11

Primary DI
00849832005131
Brand
Leica CytoVision Workgroup Data Store 1TB RAID1 11
Company
Leica Biosystems Richmond, Inc.
Model
23STR001XXX110
Device description
Leica CytoVision Workgroup Data Store 1 TB RAID1 110VAC
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
00849832005131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00849832005131008498320051318498320051310849832005131

GMDN Terms

TermDefinition
Pathology information systemA dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of pathology services and facilities. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).

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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