CHROMID® CARBA agar
GUDID 03573026409913
Selective and differential chromogenic medium for screening of rectal swabs for carbapenemase-producing Escherichia coli and Klebsiella pneumoniae.
BIOMERIEUX SA
Differential/selective agar culture medium IVD| Primary Device ID | 03573026409913 |
| NIH Device Record Key | dd8e002f-cfc5-44be-8d90-ada32574676a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CHROMID® CARBA agar |
| Version Model Number | CHROMID® CARBA 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 | 03573026409913 [Package] Contains: 03573026597719 Package: [2 Units] In Commercial Distribution |
| GS1 | 03573026597719 [Primary] |
| GS1 | 03573026597726 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181092
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 | 2 |
| Public Version Date | 2019-07-22 |
| Device Publish Date | 2018-09-28 |
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| 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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