FDA.reportPublic FDA data

Acuitas

Primary DI
04260364751024
Brand
Acuitas
Company
Curetis GmbH
Model
Acuitas AMR Gene Panel PCR Plate Kit
Catalog number
12001
Device description
PCR Assay Plate Kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) PCR Assay Plates and one (1) PCR Plate Seal Package in a labeled, white, reverse tuck box.
Published
2023-04-17
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
01812125010005PreviousGS10
20812125010000PreviousGS10
04260364751024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
01812125010005018121250100051812125010005
2081212501000020812125010000
04260364751024042603647510244260364751024

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
312621863
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260364751017AcuitasCuretis Qualified QuantStudio™ 5 Real-Time PCR Sys620062023-04-17
04260364750003UnyveroA50 Analyzer600012018-05-28
04260364751031AcuitasAcuitas AMR Gene Panel Reagent Kit120022023-03-15
04260364750058UnyveroLRT BAL Cartridge Kit100912020-01-15
04260364750010UnyveroL4 Lysator600022018-05-28
04260364750027UnyveroC8 Cockpit600032018-05-28
04260364750034UnyveroLRT Cartridge Kit100492018-05-28
04260364750041UnyveroM1 Master Mix Tube Kit100202018-05-28
04260364751000AcuitasQIAGEN® EZ1® Advanced XL System620052023-04-17

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
20812125010086AcuitasOpgen, Inc.PMY2023-04-28
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