AccessGUDID - DEVICE: Acucy System (00742860100338)

GUDID

Device Identifier (DI) Information

Brand Name: Acucy System
Version or Model: 1039
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SEKISUI DIAGNOSTICS, LLC

Primary DI Number: 00742860100338
Issuing Agency: GS1
Commercial Distribution End Date: September 24, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 966812344 *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?
42625	Photometric/spectroscopic immunoassay analyser IVD	An electrically-powered instrument intended to be used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card), after vehicle exposure to a clinical specimen, to provide a quantitative, semi-quantitative and/or qualitative in vitro determination of chemical substances and/or biological markers in the clinical specimen. The instrument uses photometry and/or light spectroscopy to detect visual markers that result from the immunological reaction between the reagents and the specimen. It is intended to be used by healthcare professionals for rapid in vitro diagnostic measurements [e.g., lateral flow immunochromatographic (ICT) test] at the point-of-care or in the laboratory.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 87305a6f-26b9-4e80-a161-d64e40b2d6bf
Public Version Date: March 08, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2019