THE SENSITITRE AIM

GUDID 00848838097409

The Sensititre Autoinoculator 2, AIM™ instrument is an automated pipette system for the delivery of user prepared inoculated media in multiples of 50 and 100 µl into the Sensititre 96 well antimicrobial susceptibility plate. The AIM™ is a bench-top instrument which dispenses bacterial suspension (inoculum) into a 96-well plate (MIC panel). The instrument has a display which presents options to the user graphically. The user may then select the well dose volume (a multiple of 50 µl) specific to each panel section. Different panel sections may be dosed differently. After selection of these parameters, the user loads the inoculum tube, a suitable panel and then starts the dosing cycle. The AIM™ is a stand-alone device and requires no connections to other equipment in normal use. It currently provides no support for sample tracking.

REMEL, INC.

Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD Antimicrobial susceptibility analyser IVD
Primary Device ID00848838097409
NIH Device Record Keyd989653e-ec29-4c68-a6d2-931ab436d08d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHE SENSITITRE AIM
Version Model NumberV3020
Company DUNS065769564
Company NameREMEL, INC.
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 Batchtrue
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
GS100848838097409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LIEReagent/Device, Inoculum Calibration

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-28
Device Publish Date2023-06-20

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