CHROMID® VRE Agar
GUDID 03573026313128
Chromogenic medium for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens.
BIOMERIEUX SA
Differential/selective agar culture medium IVD| Primary Device ID | 03573026313128 |
| NIH Device Record Key | f76c562d-1705-47cd-ade2-af147f894656 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CHROMID® VRE Agar |
| Version Model Number | chromID™ VRE Agar |
| Company DUNS | 276816717 |
| Company Name | BIOMERIEUX SA |
| Device Count | 10 |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03573026313128 [Package] Contains: 03573026552138 Package: [2 Units] In Commercial Distribution |
| GS1 | 03573026552138 [Primary] |
| GS1 | 03573026552145 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K091025
FDA Product Code
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-01-14 |
| Device Publish Date | 2016-09-23 |
Devices Manufactured by BIOMERIEUX SA
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| 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 |
Trademark Results [CHROMID]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CHROMID 86591765 4986430 Live/Registered |
bioMérieux 2015-04-09 |
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