Acuitas 12002

GUDID 04260364751031

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.

Curetis GmbH

Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD Nucleic acid amplification mastermix kit IVD

• Primary Device ID: 04260364751031
• NIH Device Record Key: 9a60088f-47cc-4481-9f29-c3816c88856d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acuitas
• Version Model Number: Acuitas AMR Gene Panel Reagent Kit
• Catalog Number: 12002
• Company DUNS: 312621863
• Company Name: Curetis GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com
• Phone: 301-869-9683
• Email: technicalsupport@opgen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	01812125010036 [Previous]
GS1	04260364751031 [Primary]
GS1	20812125010031 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191288

FDA Product Code

• PMY: System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-23
• Device Publish Date: 2023-03-15

On-Brand Devices [Acuitas]

• 04260364751031: Reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master
• 04260364751024: PCR Assay Plate Kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) PCR Assay P
• 04260364751017: QuantStudio Real-Time PCR Instrument qualified by Curetis for use with Acuitas AMR Gene Panel.
• 04260364751000: QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel.