Acuitas

Basic Information

• Brand Name: Acuitas
• Primary DI: 01812125010036
• Version / Model: KT03U01-2
• Catalog Number: KT03U01-2
• 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: 2
• Public Version Date: 2022-03-28
• Public Version Status: Update
• Public Device Record Key: 33cde9c4-a322-474a-8a83-e361808fdf5b
• Distribution End Date: 2022-03-25

Device Description

A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.

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
60091	Nucleic acid amplification mastermix kit IVD	A collection of reagents and other associated materials intended to be used in combination with sequence-specific primers, probes and/or controls to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)} in a clinical specimen, using a nucleic acid amplification technique (e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	01812125010036	GS1

Customer Contacts

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