Acuitas

Basic Information

• Brand Name: Acuitas
• Primary DI: 00812125010013
• Version / Model: CP3230
• Catalog Number: CP3230
• Company Name: Opgen, Inc.
• Labeler DUNS: 119234263
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-25
• Public Version: 2
• Public Version Date: 2023-05-26
• Public Version Status: Update
• Public Device Record Key: cd71079a-1b5d-4d2e-8605-632a03f22e42
• Distribution End Date: 2023-05-24

Device Description

Sealed, 96-well plate in Mylar Pouch. Each sealed and pouched Acuitas AMR Gene Panel PCR Plate contains four (4) panels of twenty-four (24) dried down, multiplexed PCR assays for use with the Acuitas AMR Gene Panel.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812125010013	GS1

Customer Contacts

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