AccessGUDID - DEVICE: TopazTM System (00842365100038)

GUDID

Device Identifier (DI) Information

Brand Name: TopazTM System
Version or Model: 5050412
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: AB SCIEX (MANUFACTURING)

Primary DI Number: 00842365100038
Issuing Agency: GS1
Commercial Distribution End Date: July 23, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 595281292 *Terms of Use

Device Description: No description.

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):	Yes
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?
57849	Mass spectrometry analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative determination of the chemical composition of a clinical specimen by ionizing the specimen and separating the resulting ions according to mass using an electrical and magnetic field.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DOP	Mass Spectrometer, 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: 9e5eabd5-f061-4a6e-a5cb-02ee2b2a8f83
Public Version Date: September 16, 2022
Public Version Number: 4
DI Record Publish Date: December 21, 2017