API®50 CH

GUDID 03573026087401

API 50 CH combines 50 biochemical tests for ID of Lactobacillus and related genera as well as Bacillus and related genera, Enterobacteriaceae and Vibrionaceae.

BIOMERIEUX SA

Multiple bacteria species culture isolate identification control IVD, kit Multiple bacteria species culture isolate identification control IVD, kit Multiple bacteria species culture isolate identification control IVD, kit Multiple bacteria species culture isolate identification control IVD, kit Multiple bacteria species culture isolate identification control IVD, kit Multiple bacteria species culture isolate identification control IVD, kit Multiple bacteria species culture isolate identification control IVD, kit Multiple bacteria species culture isolate identification control IVD, kit
Primary Device ID03573026087401
NIH Device Record Key2faa3697-1d3f-4130-8f51-f8bff275cde6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPI®50 CH
Version Model NumberAPI®50 CH
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

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026087401 [Package]
Contains: 03573026588694
Package: [10 Units]
In Commercial Distribution
GS103573026588694 [Primary]

FDA Product Code

JSCCULTURE MEDIA, GENERAL NUTRIENT BROTH

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.