FDA.reportPublic FDA data

Urine 1uL TS-SBA/MacCV TFS

Primary DI
09354646000087
Brand
Urine 1uL TS-SBA/MacCV TFS
Company
Clever Culture Systems AG
Model
5.1
Catalog number
AI-16054
Device description
This Analysis Module is one of the family of AM’s designed to process incubated plates to assist with the detection of Urinary Tract Infections.See https://cleverculturesystems.com for further information.
Published
2020-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PPUMicrobial Colony Image Assessment System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPUMicrobial Colony Image Assessment SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183648000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183648000APAS Independence with Urine Analysis ModuleClever Culture Systems AG2019-05-15PPU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19354646000084PackageGS11In Commercial Distribution
09354646000087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1935464600008419354646000084
09354646000087093546460000879354646000087

GMDN Terms#

Term, Definition table
TermDefinition
Microbial culture plate imaging/analysis system IVDAn electrically-powered device intended to be used for the imaging and assessment of pre-inoculated, pre-incubated microbial culture plates. It typically consists of a sample handling/preparation unit, digital camera, optical reader, transfer unit and dedicated software for image capture, processing and/or analysis. It is not intended for incubation. The system may be a single self-contained unit or modular assembly. The device operates with minimal technician involvement and complete automation of all procedural steps.

Regulatory Flags#

DUNS number
487097888
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09354646000001APAS IndependenceAAI-160012020-03-23
19354646000084Urine 1uL TS-SBA/MacCV TFS5.1AI-160542020-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
58059796360857PhenoMATRIXCOPAN WASP SRLPPU2026-02-13
09354646000001APAS IndependenceClever Culture Systems AGPPU2020-03-23
19354646000084Urine 1uL TS-SBA/MacCV TFSClever Culture Systems AGPPU2020-03-23