FDA.reportPublic FDA data

JELLOX BIOTECH INC.

Matched from indexed company URL: JelloX Biotech Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30260407913026040791JELLOX BIOTECH INC.1N2026-01-01No. 66-5, Shengyi 5th Rd., Zhubei City Hsinchu County TW 302041

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04719896180012JelloX - For In Vitro Diagnostic Use MetaLite DX Digital Pathology Software is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue for the purposes of pathology primary diagnosis. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides. MetaLite DX Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. MetaLite DX Digital Pathology Software is intended for use with Philips Ultra Fast Scanner and the Barco MDPC-8127 display.+8866583058sales@jellox.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3119812046443010K240303MetaLite DX Digital Pathology SoftwareQKQ2024-10-28
3119811070136341
3119811955528393

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QKQ12024-10-28

PMN#

GUDID#

JelloX - For In Vitro Diagnostic Use MetaLite DX Digital Pathology Software is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue for the purposes of pathology primary diagnosis. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides. MetaLite DX Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. MetaLite DX Digital Pathology Software is intended for use with Philips Ultra Fast Scanner and the Barco MDPC-8127 display.

JelloX Biotech Inc.

2026-05-18