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Expanse Laboratory/Genetics/Microbiology/Anatomical Pathology

FDA UDI

Class I (US FDA UDI)

by Medical Information Technology, Inc.

Identity

Trade Name
Expanse Laboratory/Genetics/Microbiology/Anatomical Pathology FDA UDI
Generic Name
Clinical laboratory information system application software FDA UDI
Device Name
MEDITECH's Laboratory application closely integrates requisition, specimen processing, and patient information with data in Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient collection of specimens, and result entry through seamless integration with laboratory instruments. Authorized users have the ability to view laboratory results via a specimen inquiry or a patient summary. MEDITECH's Genetics application closely integrates requisition, specimen processing, and patient information with data in an Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient collection of specimens, and result entry. Authorized users have the ability to view genetic test results via a specimen inquiry or a patient summary. MEDITECH's Microbiology application closely integrates requisition, specimen processing, and patient information with data in the Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient processing for collection and resulting of specimens including: bacteriology, mycology, parasitology, virology, and mycobacteriology. MEDITECH's Anatomical Pathology application automates the data handling needs of the Pathology department with features for recording, storing, coding, searching, and reporting Pathology cases. MEDITECH's EHR gives users the ability to view Radiology reports and lab results pertinent to the case, and to integrate relevant data into Pathology reports. Authorized users have the ability to view Anatomic Pathology results from within the network. FDA UDI
Model / Reference
Expanse FDA UDI
Description
MEDITECH's Laboratory application closely integrates requisition, specimen processing, and patient information with data in Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient collection of specimens, and result entry through seamless integration with laboratory instruments. Authorized users have the ability to view laboratory results via a specimen inquiry or a patient summary. MEDITECH's Genetics application closely integrates requisition, specimen processing, and patient information with data in an Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient collection of specimens, and result entry. Authorized users have the ability to view genetic test results via a specimen inquiry or a patient summary. MEDITECH's Microbiology application closely integrates requisition, specimen processing, and patient information with data in the Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient processing for collection and resulting of specimens including: bacteriology, mycology, parasitology, virology, and mycobacteriology. MEDITECH's Anatomical Pathology application automates the data handling needs of the Pathology department with features for recording, storing, coding, searching, and reporting Pathology cases. MEDITECH's EHR gives users the ability to view Radiology reports and lab results pertinent to the case, and to integrate relevant data into Pathology reports. Authorized users have the ability to view Anatomic Pathology results from within the network. FDA UDI

Identifiers

Primary DI / UDI-DI
00863529000155 FDA UDI
FDA Product Code
JQP FDA UDI
GMDN Term
Clinical laboratory information system application software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Clinical laboratory information system application software

Expanse Laboratory/Genetics/Microbiology/Anatomical Pathology by Medical Information Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Clinical laboratory information system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Information Technology, Inc.

Sources (1)

  • FDA UDI 29bd5452-f0b0-4cd6-80fe-979ec506dc37 33 fields · synced Jun 1, 2026