FDA.reportPublic FDA data

Acuitas

Primary DI
04260364751031
Brand
Acuitas
Company
Curetis GmbH
Model
Acuitas AMR Gene Panel Reagent Kit
Catalog number
12002
Device description
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.
Published
2023-03-15
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
01812125010036PreviousGS10
20812125010031PreviousGS10
04260364751031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
01812125010036018121250100361812125010036
2081212501003120812125010031
04260364751031042603647510314260364751031

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid amplification mastermix kit IVDA 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)].

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
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
04260364751024AcuitasAcuitas AMR Gene Panel PCR Plate Kit120012023-04-17

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
04260364751024AcuitasCuretis GmbHPMY2023-04-17
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