APAS Independence AI-16001

GUDID 09354646000001

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.

Clever Culture Systems AG

Microbial culture plate imaging/analysis system IVD
Primary Device ID09354646000001
NIH Device Record Key19f5f5a7-c60f-438d-92a8-88df6c95ba68
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPAS Independence
Version Model NumberA
Catalog NumberAI-16001
Company DUNS487097888
Company NameClever Culture Systems AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109354646000001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PPUMicrobial Colony Image Assessment System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-31
Device Publish Date2020-03-23

Devices Manufactured by Clever Culture Systems AG

09354646000001 - APAS Independence2020-03-31The 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.
09354646000001 - APAS Independence2020-03-31 The APAS Independence is intended to be used by a microbiology laboratory to read, interpret and sort culture plates in order to
19354646000084 - Urine 1uL TS-SBA/MacCV TFS2020-03-31 This Analysis Module is one of the family of AM’s designed to process incubated plates to assist with the detection of Urinary

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