Primary Device ID | 03573026560911 |
NIH Device Record Key | aea42caa-bd0f-4e3d-b67b-dc935d83f40d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Etest® PLAZOMICIN |
Version Model Number | Etest® PLAZOMICIN |
Company DUNS | 276816717 |
Company Name | BIOMERIEUX SA |
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 | true |
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 -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03573026560911 [Package] Contains: 03573026603229 Package: [30 Units] In Commercial Distribution |
GS1 | 03573026603229 [Primary] |
JWY | Manual antimicrobial susceptibility test systems |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-07-27 |
Device Publish Date | 2020-07-19 |
03573026256685 - ETEST® Gentamicin (GM) | 2024-04-15 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1 |
03573026376604 - ETEST® Amoxicillin (AC) | 2024-04-15 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1 |
03573026377731 - ETEST® Flucytosine (FC) | 2024-04-15 Etest is a quantitative technique for determining susceptibility of antifungal. It provides a gradient of 15 doubling dilutions |
03573026560690 - ETEST® Meropenem/Vaborbactam (MEV) | 2024-04-15 ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative an |
03573026475352 - ETEST® Telavancin (TLA) | 2024-04-12 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1 |
03573026252526 - ETEST® Cefepime (PM) | 2024-04-08 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1 |
03573026253219 - Etest® TIC/CLAV-CON2 | 2024-04-08 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1 |
03573026617851 - VITEK®MS | 2024-03-18 VITEK MS ready to use reagent for calibration and fine tuning of the VITEK MS instrument |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ETEST 86858560 5121999 Live/Registered |
AB bioMérieux 2015-12-28 |
ETEST 79046072 3598623 Live/Registered |
AB bioMérieux 2007-10-04 |
ETEST 75645957 not registered Dead/Abandoned |
Cognizant Design Group, Inc. 1999-02-19 |
ETEST 75643429 not registered Dead/Abandoned |
Employment Screening Partners, Inc. 1999-02-18 |
ETEST 75495001 2330282 Live/Registered |
ETEST, INC. 1998-06-02 |
ETEST 73799188 1682607 Live/Registered |
AB BIODISK 1989-05-11 |