TDNexLabs - TDNexLabs is a Laboratory Information System - TECHNIDATA

Duns Number:383120136

Device Description: TDNexLabs is a Laboratory Information System (LIS) (software product) intended to be used TDNexLabs is a Laboratory Information System (LIS) (software product) intended to be used for the management of clinical information.TDNexLabs is intended to be used only by health professionals.

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More Product Details

Catalog Number

-

Brand Name

TDNexLabs

Version/Model Number

TDNexLabs

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JQP

Product Code Name

Calculator/Data Processing Module, For Clinical Use

Device Record Status

Public Device Record Key

4275977d-9681-48eb-ba1b-f62ebf9eab80

Public Version Date

August 16, 2022

Public Version Number

1

DI Record Publish Date

August 08, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TECHNIDATA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4