APAS Independence

Primary DI
09354646000001
Brand
APAS Independence
Company
Clever Culture Systems AG
Model
A
Catalog number
AI-16001
Device description
The APAS Independence is intended to be used by a microbiology laboratory to read, interpret and sort culture plates in order to screen for the presence of microbial growth relevant for specific clinical conditions (e.g. urinary tract infection).The instrument may host multiple Analysis Modules, each of which is used to screen for a specific purpose.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
09354646000001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09354646000001093546460000019354646000001

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09354646000087Urine 1uL TS-SBA/MacCV TFS5.1AI-160542020-03-23
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
09354646000087Urine 1uL TS-SBA/MacCV TFSClever Culture Systems AGPPU2020-03-23
19354646000084Urine 1uL TS-SBA/MacCV TFSClever Culture Systems AGPPU2020-03-23