DensiCHEK™ plus

GUDID 03573026222239

The DensiCHEK™ Plus instrument is designed for use with the VITEK®2 System to measure the optical density of a microorganism suspension.

BIOMERIEUX , INC.

Photometer, absorbance/transmission, automated
Primary Device ID03573026222239
NIH Device Record Keyb65a4cca-04b7-4202-9843-549715fa88a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameDensiCHEK™ plus
Version Model Number21250
Company DUNS086785110
Company NameBIOMERIEUX , INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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 -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026222239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-04-07
Device Publish Date2016-11-30

Devices Manufactured by BIOMERIEUX , INC.

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00860007326905 - VITEK® REVEAL™2024-10-17 The VITEK REVEAL Instrument is a benchtop instrument that processes up to four AST tests . Installation and operating details f
00860007326912 - VITEK® REVEAL™ SEALER2024-10-17 The VITEK REVEAL SEALER provides the heat welding of the VITEK REVEAL SENSOR PANEL to the 96 well AST Drug Plate.
03573026638900 - VITEK® REVEAL™ SENSOR PANEL2024-10-17 The VITEK REVEAL Reveal AST Assays are indicated for susceptibility testing of pathogenic bacteria
03573026636357 - VITEK® 2 AST-N8142023-12-14 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026635978 - VITEK® 2 AST-N8092023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026636142 - VITEK® 2 AST-N8112023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026636296 - VITEK® 2 AST-N8122023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin

Trademark Results [DensiCHEK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DENSICHEK
DENSICHEK
87263161 5259933 Live/Registered
bioMerieux Inc.
2016-12-09

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