BacT/ALERT®3D Left Incubator Module
GUDID 03573026049577
the BacT/ALERT 3D Left Incubator Module has four independent drawers of 60 cells each. Patented cell flags track bottle movements between cells for greater ease of use.
BIOMERIEUX , INC.
Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD| Primary Device ID | 03573026049577 |
| NIH Device Record Key | 10386246-bd03-453c-93a0-d187491f551f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BacT/ALERT®3D Left Incubator Module |
| Version Model Number | 210159 |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03573026049577 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K903505
FDA Product Code
| MDB | System, blood culturing |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-02 |
| Device Publish Date | 2020-10-23 |
Devices Manufactured by BIOMERIEUX , INC.
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| 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 |
| 03573026636319 - VITEK® 2 AST-N813 | 2023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin |
| 03573026636333 - VITEK® 2 AST-XN33 | 2023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin |
| 03573026636128 - VITEK® 2 AST-N810 | 2023-11-09 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin |
| 03573026636067 - VITEK® 2 AST-N804 | 2023-10-04 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin |
Trademark Results [BacT/ALERT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BACT/ALERT 77523447 3962173 Live/Registered |
bioMérieux, Inc. 2008-07-16 |
 BACT/ALERT 75022103 2017525 Live/Registered |
BIOMERIEUX, INC. 1995-11-20 |
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