Acuitas

Basic Information

• Brand Name: Acuitas
• Primary DI: 01812125010005
• Version / Model: KT03U01-1
• Catalog Number: KT03U01-1
• Company Name: Opgen, Inc.
• Labeler DUNS: 119234263
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-06
• Public Version: 3
• Public Version Date: 2022-03-28
• Public Version Status: Update
• Public Device Record Key: 132b0fa7-ea4e-4487-9b53-93e8b5584827
• Distribution End Date: 2022-03-25

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PMY	System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony	Microbiology	866.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	01812125010005	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]