AccessGUDID - DEVICE: Acuitas (00812125010020)

GUDID

Device Identifier (DI) Information

Brand Name: Acuitas
Version or Model: CP3445
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CP3445
Company Name: Opgen, Inc.

Primary DI Number: 00812125010020
Issuing Agency: GS1
Commercial Distribution End Date: May 24, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 119234263 *Terms of Use

Device Description: PCR Plate Seal Package component of KT03U01-1 Acuitas AMR Gene Panel PCR Assay Plate Kit consisting of two (2) PCR Plate Seals pouched in a labeled clear plastic bag.

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:	Yes
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?
61305	Assay adhesive sealing/fixation film IVD	A thin adhesive film intended to be used during in vitro diagnostic assays typically to seal the top of a microplate to prevent sample carryover and/or evaporation, and/or to fix test strips to a surface/chart to facilitate analysis. It is typically made of aluminium foil or plastic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PMY	System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony

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: 4734aed2-cb37-4607-8af0-db5cf297b252
Public Version Date: May 26, 2023
Public Version Number: 3
DI Record Publish Date: October 25, 2021