API® 20 C AUX

GUDID 03573026048082

API 20 C AUX is a system for the precise identification of the most frequently encountered yeasts.

BIOMERIEUX SA

Multiple Candida/yeast species culture isolate identification IVD, kit
Primary Device ID03573026048082
NIH Device Record Keya3b6a6af-a509-458b-bc21-273bc54d6b61
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPI® 20 C AUX
Version Model Number20210
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 Kittrue
Device Combination Productfalse
Single Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026048082 [Primary]

FDA Product Code

JXBKIT, IDENTIFICATION, YEAST

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

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