FDA.reportPublic FDA data

HistoPro®

Primary DI
B92114709
Brand
HistoPro®
Company
RUSHABH INSTRUMENTS, LLC
Model
600
Catalog number
14709
Device description
Rapid Tissue Processor
Published
2022-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
B92114709PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tissue processor IVD, automated/semi-automatedAn electrically-powered automated or semi-automated 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.

Contacts#

Phone, Email table
PhoneEmail
2154910081wecare@rushabhinstruments.com

Regulatory Flags#

DUNS number
161907139
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B921119650HistoPro®150H, 115V1196502022-12-18
B921119651HistoPro®150H, 230V1196512022-12-18
B921119660HistoPro®150CS, 115V1196602022-12-18
B921119661HistoPro®150CS, 230V1196612022-12-18
B92112631HistoPro®3030, 115V126312022-12-17
B92112691HistoPro®3030, 230V126912022-12-17
B92113917HistoPro®2430139172022-12-17
B92114667HistoPro®650H, 115V146672022-12-18
B92114668HistoPro®650CS, 115V146682022-12-18
B92114669HistoPro®650H, 230V146692022-12-18
B92114670HistoPro®650CS, 230V146702022-12-18
B92115391HistoPro®620153912022-12-17
B92113401HistoPro®414134012022-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551020410009PathTezt®BIOCYTECH CORPORATION SDN. BHD.IEO2026-03-11
09551020410016PathTezt®BIOCYTECH CORPORATION SDN. BHD.IEO2026-03-11
04946433600584Tissue-VIP® 6 AISAKURA FINETEK U.S.A., INC.IEO2024-10-11
05051663518581EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-06-13
05051663518598EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-06-13
05051663518604EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-06-13
05051663517294EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517317EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517324EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517331EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517348EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517355EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517546EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517553EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517577EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517607EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517614EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517621EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517683EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517850EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517867EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
09349458005573HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2023-08-30
09349458005580HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2023-08-30
05051663009386EprediaSHANDON DIAGNOSTICS LIMITEDIEO2023-07-28
09349458004811HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-20
09349458004712HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-18
09349458004729HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-18
09349458004736HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-18
09349458004743HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-18
09349458005559HistoCore PELORIS LEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-18