VITEK 2

GUDID 03573026605674

VITEK DENSICHEK CONNECTIVITY BASE Kit that include one pod and one connecrtivity base

BIOMERIEUX , INC.

Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated Photometer, absorbance/transmission, automated

Primary Device ID	03573026605674
NIH Device Record Key	ea766199-eec0-45e9-984f-707a85027386
Commercial Distribution Status	In Commercial Distribution
Brand Name	VITEK 2
Version Model Number	422221
Company DUNS	086785110
Company Name	BIOMERIEUX , INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -15 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026605674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K192110

FDA Product Code

LON	SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-12-17
Device Publish Date	2019-12-09

On-Brand Devices [VITEK 2]

03573026605667	The DISPLAY is part of the VITEK DensiCHEK that allows to read the McFarland value for a bacteri
03573026605674	VITEK DENSICHEK CONNECTIVITY BASE Kit that include one pod and one connecrtivity base