AccessGUDID - DEVICE: Infinite F50 (09120052070347)

GUDID

Device Identifier (DI) Information

Brand Name: Infinite F50
Version or Model: 30084265 01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 30084265
Company Name: Tecan Austria GmbH

Primary DI Number: 09120052070347
Issuing Agency: GS1
Commercial Distribution End Date: November 26, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 301237509 *Terms of Use

Device Description: The Infinite F50 is an absorbance microplate reader for ELISA. It includes Magellan™for Infinite F50 reader control and data analysis software.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57862	Microplate reader IVD, automated/semi-automated	An electrically-powered automated or semi-automated laboratory instrument intended to be used to photometrically measure the optical absorbance or emission of clinical specimens in microplates containing multiple individual sample wells, with or without a separate cuvette-reading station. The device utilizes technology which may include reagent dispensing, a single or dual lightsource, bandpass filters, monochromators, photodetectors, data processing software and/or data displays to determine the qualitative and/or quantitative values of biological constituents of a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: df83ecf7-44bb-4f7b-8978-f55c24257699
Public Version Date: September 16, 2022
Public Version Number: 4
DI Record Publish Date: July 12, 2020