FDA.reportPublic FDA data

Acuitas

Primary DI
10812125010010
Brand
Acuitas
Company
Opgen, Inc.
Model
CP3230
Catalog number
CP3230
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.
Published
2023-04-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
10812125010010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081212501001010812125010010

GMDN Terms#

Term, Definition table
TermDefinition
Microplate IVDA 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
119234263
Device count
1
Lot or batch
true
Expiration date on label
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
10812125010027AcuitasCP3445CP34452023-04-28
10812125010041AcuitasCP3233CP32332023-04-28
20812125010079AcuitasAC043AC0432023-04-28
00812125010013AcuitasCP3230CP32302021-10-25
00812125010020AcuitasCP3445CP34452021-10-25
00812125010044AcuitasCP3233CP32332021-10-25
20812125010086AcuitasCP3511CP35112023-04-28
01812125010074AcuitasAC043AC0432021-10-25
01812125010081AcuitasCP3511CP35112021-10-25
01812125010005AcuitasKT03U01-1KT03U01-12021-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
20812125010086AcuitasOpgen, 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