FDA.reportPublic FDA data

Leica ASP300 S

Primary DI
04049188055965
Brand
Leica ASP300 S
Company
Leica Biosystems Nussloch GmbH
Model
000000014047643515
Catalog number
14047643515
Device description
The instrument has been designed so that it is safe to use by the operator as well as for process¬ing specimens – provided that it is operated according to the present Instructions for Use. The Leica ASP300 S is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Paraffin infiltration of histological tissue specimens.
Published
2018-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IEOPROCESSOR, TISSUE, AUTOMATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IEOProcessor, Tissue, AutomatedPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049188055965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049188055965040491880559654049188055965

GMDN Terms#

Term, Definition table
TermDefinition
Tissue processor IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the processing of clinical tissue specimens [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination. The device may be a single unit or modular assembly. 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
+4962241430CHS.support@LeicaBiosystems.co
+4962241430CHS.support@LeicaBiosystems.com

Regulatory Flags#

DUNS number
315539452
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049188210777ASP6025 S 230V/50-60Hz000000014049559058140495590582019-07-05
04049188210784ASP6025 S 120V/50-60Hz000000014049559068140495590682019-07-05
04049188210791ASP6025 S China000000014049559088140495590882019-07-05
04049188216397HistoCore PEGASUS000000014048858005140488580052021-11-02
04049188217769HistoCore PEGASUS Plus000000014048858007140488580072021-11-02
04049188003102Leica TP1020 VF/accessories1491020US021491020US022018-12-04
04049188003119Leica TP1020 F /accessories1491020US011491020US012018-12-04
04049188055903Basket set Leica ASP300 S000000014047643576140476435762018-12-04
04049188055972Leica ASP300 S - 230-240V000000014047643514140476435142018-12-04
04049188056146Leica ASP300 S - China000000014047643057140476430572018-12-04
04049188057334Basket, assy., large000000014047634782140476347822018-12-04
04049188058423Basket000000014047634194140476341942018-12-04
04049188087706Leica TP1020 with Chloroform000000014042242238140422422382018-11-16
04049188087843Tissue basket - Cone000000014042232564140422325642018-12-04
04049188087973Flexible tube 50x4000000000014042231975140422319752018-12-04
04049188087980Flexible tube 50x2000000000014042231974140422319742018-12-04
04049188088246Leica TP1020 (Double loading) Without vaccum/w000000014042231418140422314182018-11-16
04049188088253Leica TP1020 (Double loading) With fume control000000014042231416140422314162018-11-16
04049188088260Leica TP1020 (Double loading) With vacuum/ without fume control000000014042231414140422314142018-11-16
04049188088284Leica TP1020 (Double loading) With vacuum/ with fume control000000014042231412140422314122018-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551020410009PathTezt®BIOCYTECH CORPORATION SDN. BHD.IEO2026-03-11
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04946433600584Tissue-VIP® 6 AISAKURA FINETEK U.S.A., INC.IEO2024-10-11
05051663518581EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-06-13
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09349458005580HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2023-08-30
05051663009386EprediaSHANDON DIAGNOSTICS LIMITEDIEO2023-07-28
B92114709HistoPro®RUSHABH INSTRUMENTS, LLCIEO2022-12-18
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