FDA.report

Leica Biosystems CytoVision Kit, Barcode Reader &

Primary DI
00849832010203
Brand
Leica Biosystems CytoVision Kit, Barcode Reader &
Company
Leica Biosystems Richmond, Inc.
Model
23GSLS0006
Device description
Leica Biosystems CytoVision Kit, Barcode Reader & Cables
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
00849832010203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00849832010203008498320102038498320102030849832010203

GMDN Terms

TermDefinition
Barcode readerA device that reads and interprets barcodes of various format. A barcode is typically an electronically readable information strip consisting of parallel, vertical stripes and spaces of variable thicknesses which can also be presented in two or more layered information levels. This device may have the capability of storing the read data and downloading this into other data systems when this is required.

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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