Primary Device ID | 03573026464387 |
NIH Device Record Key | 17bc9be5-a138-4c3e-8dfe-8a4218a5824c |
Commercial Distribution Discontinuation | 2018-12-28 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | RAPIDEC® CARBA NP |
Version Model Number | RAPIDEC® CARBA NP |
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 | 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 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03573026464387 [Primary] |
PTJ | Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-11-01 |
Device Publish Date | 2017-07-04 |
03573026626891 - VIDAS® TBI (GFAP, UCH-L1) | 2024-11-08 VIDAS TBI (GFAP, UCH-L1) is an automated quantitative test to be used on VIDAS3. It is intended to be used as an aid in the eval |
03573026359096 - VITEK® MS-DS | 2024-04-30 The VITEK MS-DS target slides enable the identification of microorganisms according to the MALDI-TOF mass spectrometry method. |
03573026359119 - VITEK® MS | 2024-04-29 MALDI-Tof Mass Spectrometry system used for microbial identification |
03573026362843 - VITEK® MS FA | 2024-04-29 VITEK ® MS - FA is used to pretreat yeasts to facilitate their identification according to the MALDI - TOF method. It is used e |
03573026619527 - VIDAS® PC SOFTWARE V4.9 | 2024-04-29 VIDAS PC V4.9 W10 Software version for clinic |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RAPIDEC 73643870 1465264 Live/Registered |
API SYSTEM, S.A. 1987-02-09 |