Primary Device ID | 09354646000001 |
NIH Device Record Key | 19f5f5a7-c60f-438d-92a8-88df6c95ba68 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | APAS Independence |
Version Model Number | A |
Catalog Number | AI-16001 |
Company DUNS | 487097888 |
Company Name | Clever Culture Systems AG |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 09354646000001 [Primary] |
PPU | Microbial Colony Image Assessment System |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-03-31 |
Device Publish Date | 2020-03-23 |
09354646000001 - APAS Independence | 2020-03-31The 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 Independence | 2020-03-31 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 TFS | 2020-03-31 This Analysis Module is one of the family of AM’s designed to process incubated plates to assist with the detection of Urinary |