Primary Device ID | 03573026222222 |
NIH Device Record Key | 767654ff-bba5-4640-9a67-9abba5c76ba8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DensiCHEK™ Plus Standards |
Version Model Number | 21255 |
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 | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03573026222222 [Primary] |
LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 6 |
Public Version Date | 2021-05-10 |
Device Publish Date | 2016-11-30 |
03573026641337 - VITEK® 2 AST-N815 | 2024-11-21 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin |
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™ SEALER | 2024-10-17 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 PANEL | 2024-10-17 The VITEK REVEAL Reveal AST Assays are indicated for susceptibility testing of pathogenic bacteria |
03573026636357 - VITEK® 2 AST-N814 | 2023-12-14 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-N809 | 2023-11-10 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-N811 | 2023-11-10 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-N812 | 2023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DENSICHEK 87263161 5259933 Live/Registered |
bioMerieux Inc. 2016-12-09 |