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Instrument Manager

FDA UDI

Class II (US FDA UDI)

by Data Innovations, Llc

Identity

Trade Name
Instrument Manager FDA UDI
Generic Name
Clinical laboratory information system application software FDA UDI
Device Name
Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management. FDA UDI
Model / Reference
816 FDA UDI
Description
Instrument Manager is a stand-alone software application that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. Instrument Manager is a software package intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management. FDA UDI

Identifiers

Catalog Number
IMB02816 FDA UDI
Primary DI / UDI-DI
B180IMB028160 FDA UDI
FDA Product Code
MMH FDA UDI
GMDN Term
Clinical laboratory information system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9165 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Clinical laboratory information system application software

Instrument Manager by Data Innovations, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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
Data Innovations, Llc

Sources (1)

  • FDA UDI a1589182-c234-45f0-aefd-ba1dfe20250c 34 fields · synced May 30, 2026