FDA.reportPublic FDA data

Acuitas

Primary DI
01812125010067
Brand
Acuitas
Company
Opgen, Inc.
Model
AC042
Catalog number
AC042
Device description
QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel.
Published
2021-10-25
Public version status
Update
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
OOIReal Time Nucleic Acid Amplification System
PMYSystem, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
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
01812125010067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
01812125010067018121250100671812125010067

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratory, automatedAn electrically-powered laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification, and operates with minimal technician input and complete automation of all procedural steps.

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
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
20812125010086AcuitasCP3511CP35112023-04-28
01812125010074AcuitasAC043AC0432021-10-25
01812125010081AcuitasCP3511CP35112021-10-25
01812125010005AcuitasKT03U01-1KT03U01-12021-10-06

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