Home GUDID 19354646000084 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 Code Name PPU Microbial Colony Image Assessment System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PPU Microbial Colony Image Assessment System Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 19354646000084 Package GS1 1 In Commercial Distribution 09354646000087 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 19354646000084 19354646000084 09354646000087 09354646000087 9354646000087
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 DI Brand Model Catalog Published 09354646000087 Urine 1uL TS-SBA/MacCV TFS 5.1 AI-16054 2020-03-23 09354646000001 APAS Independence A AI-16001 2020-03-23
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 58059796360857 PhenoMATRIX COPAN WASP SRL PPU 2026-02-13 09354646000087 Urine 1uL TS-SBA/MacCV TFS Clever Culture Systems AG PPU 2020-03-23 09354646000001 APAS Independence Clever Culture Systems AG PPU 2020-03-23