API 20 E™

GUDID 03573026048013

API 20 E is a standardized identification system for Enterobacteriaceae and other non-fastidious, Gramnegative rods

BIOMERIEUX SA

Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit Multiple gram negative bacteria species culture isolate identification IVD, kit
Primary Device ID03573026048013
NIH Device Record Key731c4370-d4ac-4aa4-b10c-1ec2769d19a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPI 20 E™
Version Model NumberAPI 20 E™
Company DUNS276816717
Company NameBIOMERIEUX SA
Device Count25
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
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
GS103573026047818 [Package]
Contains: 03573026588489
Package: [1 Units]
In Commercial Distribution
GS103573026048013 [Package]
Contains: 03573026588489
Package: [4 Units]
In Commercial Distribution
GS103573026588489 [Primary]
GS103573026588496 [Unit of Use]

FDA Product Code

JSSKIT, IDENTIFICATION, ENTEROBACTERIACEAE

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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Trademark Results [API 20 E]

Mark Image

Registration | Serial
Company
Trademark
Application Date
API 20 E
API 20 E
75926888 2533515 Dead/Cancelled
bioMerieux, Inc.
2000-02-23

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