FDA.reportPublic FDA data

CytoVision GSL 120 Robotics Upgrade for Karyo/ FISH

Primary DI
00849832013327
Brand
CytoVision GSL 120 Robotics Upgrade for Karyo/ FISH
Company
Leica Biosystems Richmond, Inc.
Model
23GSL120KFXROB
Device description
CytoVision GSL 120 Robotics Upgrade for Karyo/ FISH
Published
2018-06-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOYDEVICE, AUTOMATED CELL-LOCATING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOYDevice, Automated Cell-LocatingHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042542000CYTOVISION FOR CEP XYApplied Imaging Corp.2005-01-10NTH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849832013327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849832013327008498320133278498320133270849832013327

GMDN Terms#

Term, Definition table
TermDefinition
Cell morphology analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used to capture digital images of a clinical specimen at the microscopic level in order to view, count, record and evaluate the morphological characteristics of the cells and other biological components. It is a computerized optical unit consisting of a microscope, camera and software. The device operates with minimal technician involvement and complete automation of all procedural steps.

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.com

Regulatory Flags#

DUNS number
082930884
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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

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