AccessGUDID - DEVICE: Acuitas (01812125010005)

GUDID

Device Identifier (DI) Information

Brand Name: Acuitas
Version or Model: KT03U01-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: KT03U01-1
Company Name: Opgen, Inc.

Primary DI Number: 01812125010005
Issuing Agency: GS1
Commercial Distribution End Date: March 25, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 119234263 *Terms of Use

Device Description: PCR Assay Plate Kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) PCR Assay Plates and one (1) PCR Plate Seal Package in a labeled, white, reverse tuck box.

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:	Yes
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?
61296	Microplate IVD	A plate with multiple wells designed to contain small volumes of clinical specimens, reagents, or other materials for testing procedures performed by a laboratory analyser. It is typically made of sterilizable plastic material (e.g., polypropylene) and is used with manual or automated analysers. This is a single-use device.	Active	false
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: 132b0fa7-ea4e-4487-9b53-93e8b5584827
Public Version Date: March 28, 2022
Public Version Number: 3
DI Record Publish Date: October 06, 2021