FDA.reportPublic FDA data

Urine 1uL TS-SBA/MacCV TFS

Primary DI
19354646000084
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
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
487097888
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09354646000087Urine 1uL TS-SBA/MacCV TFS5.1AI-160542020-03-23
09354646000001APAS IndependenceAAI-160012020-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
58059796360857PhenoMATRIXCOPAN WASP SRLPPU2026-02-13
09354646000087Urine 1uL TS-SBA/MacCV TFSClever Culture Systems AGPPU2020-03-23
09354646000001APAS IndependenceClever Culture Systems AGPPU2020-03-23