rapid ID 32 A

GUDID 03573026066420

rapid ID 32 A is a standardized system for the identification of anaerobes in 4 hours

BIOMERIEUX SA

Multiple anaerobic bacteria species culture isolate identification IVD, kit Multiple anaerobic bacteria species culture isolate identification IVD, kit Multiple anaerobic bacteria species culture isolate identification IVD, kit Multiple anaerobic bacteria species culture isolate identification IVD, kit Multiple anaerobic bacteria species culture isolate identification IVD, kit Multiple anaerobic bacteria species culture isolate identification IVD, kit Multiple anaerobic bacteria species culture isolate identification IVD, kit Multiple anaerobic bacteria species culture isolate identification IVD, kit Multiple anaerobic bacteria species culture isolate identification IVD, kit Multiple anaerobic bacteria species culture isolate identification IVD, kit Multiple anaerobic bacteria species culture isolate identification IVD, kit Multiple anaerobic bacteria species culture isolate identification IVD, kit Multiple anaerobic bacteria species culture isolate identification IVD, kit Multiple anaerobic bacteria species culture isolate identification IVD, kit Multiple anaerobic bacteria species culture isolate identification IVD, kit
Primary Device ID03573026066420
NIH Device Record Key9e8c288b-b368-417a-a00b-8bc1c42cf16a
Commercial Distribution StatusIn Commercial Distribution
Brand Namerapid ID 32 A
Version Model Numberrapid ID 32 A
Company DUNS276816717
Company NameBIOMERIEUX SA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026066420 [Package]
Contains: 03573026588564
Package: [25 Units]
In Commercial Distribution
GS103573026588564 [Primary]

FDA Product Code

JSPKIT, ANAEROBIC IDENTIFICATION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-20
Device Publish Date2020-04-10

Devices Manufactured by BIOMERIEUX SA

03573026256685 - ETEST® Gentamicin (GM)2024-04-15 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1
03573026376604 - ETEST® Amoxicillin (AC)2024-04-15 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1
03573026377731 - ETEST® Flucytosine (FC)2024-04-15 Etest is a quantitative technique for determining susceptibility of antifungal. It provides a gradient of 15 doubling dilutions
03573026560690 - ETEST® Meropenem/Vaborbactam (MEV)2024-04-15 ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative an
03573026475352 - ETEST® Telavancin (TLA)2024-04-12 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1
03573026252526 - ETEST® Cefepime (PM)2024-04-08 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1
03573026253219 - Etest® TIC/CLAV-CON22024-04-08 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1
03573026617851 - VITEK®MS2024-03-18 VITEK MS ready to use reagent for calibration and fine tuning of the VITEK MS instrument

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.