FDA.reportPublic FDA data

Acuitas

Primary DI
20812125010086
Brand
Acuitas
Company
Opgen, Inc.
Model
CP3511
Catalog number
CP3511
Device description
Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software.
Published
2023-04-28
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMYSystem, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMYSystem, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, ColonyMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191288000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191288000Acuitas AMR Gene PanelOpgen, Inc.2021-09-30PMY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20812125010086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081212501008620812125010086

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDAn in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
301-869-9683technicalsupport@opgen.com

Regulatory Flags#

DUNS number
119234263
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20812125010062AcuitasAC042AC0422023-04-28
01812125010067AcuitasAC042AC0422021-10-25
10812125010058AcuitasCP3402CP34022023-04-28
20812125010031AcuitasKT03U01-2KT03U01-22023-04-28
00812125010051AcuitasCP3402CP34022021-10-25
01812125010036AcuitasKT03U01-2KT03U01-22021-10-06
20812125010000AcuitasKT03U01-1KT03U01-12023-04-28
10812125010010AcuitasCP3230CP32302023-04-28
10812125010027AcuitasCP3445CP34452023-04-28
10812125010041AcuitasCP3233CP32332023-04-28
20812125010079AcuitasAC043AC0432023-04-28
00812125010013AcuitasCP3230CP32302021-10-25
00812125010020AcuitasCP3445CP34452021-10-25
00812125010044AcuitasCP3233CP32332021-10-25
01812125010074AcuitasAC043AC0432021-10-25
01812125010081AcuitasCP3511CP35112021-10-25
01812125010005AcuitasKT03U01-1KT03U01-12021-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10812125010010AcuitasOpgen, Inc.PMY2023-04-28
10812125010027AcuitasOpgen, Inc.PMY2023-04-28
10812125010041AcuitasOpgen, Inc.PMY2023-04-28
10812125010058AcuitasOpgen, Inc.PMY2023-04-28
20812125010000AcuitasOpgen, Inc.PMY2023-04-28
20812125010031AcuitasOpgen, Inc.PMY2023-04-28
20812125010062AcuitasOpgen, Inc.PMY2023-04-28
20812125010079AcuitasOpgen, Inc.PMY2023-04-28
04260364751024AcuitasCuretis GmbHPMY2023-04-17
04260364751031AcuitasCuretis GmbHPMY2023-03-15
00812125010013AcuitasOpgen, Inc.PMY2021-10-25
00812125010020AcuitasOpgen, Inc.PMY2021-10-25
00812125010044AcuitasOpgen, Inc.PMY2021-10-25
00812125010051AcuitasOpgen, Inc.PMY2021-10-25
01812125010067AcuitasOpgen, Inc.PMY2021-10-25
01812125010074AcuitasOpgen, Inc.PMY2021-10-25
01812125010081AcuitasOpgen, Inc.PMY2021-10-25
01812125010005AcuitasOpgen, Inc.PMY2021-10-06
01812125010036AcuitasOpgen, Inc.PMY2021-10-06
00840733102370Revogene Carba CMERIDIAN BIOSCIENCE, INC.PMY2020-07-15
00628055344162Revogene® Carba CMeridian Bioscience Canada IncPMY2019-10-21
00628055344070GenePOC™ CarbaGenePoc IncPMY2019-05-24
07332940001032Xpert Carba-RCEPHEIDPMY2018-01-29