Unyvero

Primary DI
04260364750034
Brand
Unyvero
Company
Curetis GmbH
Model
LRT Cartridge Kit
Catalog number
10049
Device description
Kit of 12 disposable Unyvero LRT Cartridges, including sample tubes, sample tube caps and sample transfer tools, for testing 12 patient samples in total. Each sample also requires 1 Unyvero M1 Master Mix Tube for processing (not contained in this kit)
Published
2018-05-28
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
QBHLower respiratory microbial nucleic acid detection system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBHLower Respiratory Microbial Nucleic Acid Detection SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170047000Curetis Unyvero LRT ApplicationCuretis GmbH2018-04-03QBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260364750034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260364750034042603647500344260364750034

GMDN Terms#

Term, Definition table
TermDefinition
Multiple respiratory disease-associated bacteria/antimicrobial resistance nucleic acid IVD, kit, nucleic acid techniqueA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple bacteria associated with respiratory disease in a clinical specimen, and/or one or multiple genes conferring antimicrobial resistance in the respiratory isolates detected, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydophila psittaci, C. pneumoniae (Chlamydia pneumoniae), Coxiella burnetii, Legionella pneumophila and/or Bordetella pertussis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(619)452-3644support_us@curetis.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
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
04260364750058UnyveroCuretis GmbHQBH2020-01-15
00815381020178FilmArray® Pneumonia Panel (Pneumo)BIOFIRE DIAGNOSTICS, LLCQBH2018-12-12
00815381020185FilmArray® Pneumonia Panel (Pneumo)BIOFIRE DIAGNOSTICS, LLCQBH2018-12-12
04260364750003UnyveroCuretis GmbHQBH2018-05-28
04260364750010UnyveroCuretis GmbHQBH2018-05-28
04260364750027UnyveroCuretis GmbHQBH2018-05-28
04260364750041UnyveroCuretis GmbHQBH2018-05-28