BACT/ALERT® PF PLUS
GUDID 03573026357924
The BACT/ALERT PF Plus Culture Bottles are used for recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.
BIOMERIEUX , INC.
Basic/simple nutrient broth culture medium IVD| Primary Device ID | 03573026357924 |
| NIH Device Record Key | 0a407d92-bc25-4b50-bd30-c5af3e68ae6c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BACT/ALERT® PF PLUS |
| Version Model Number | BACT/ALERT® PF PLUS |
| 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 | 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 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03573026357924 [Package] Contains: 03573026611910 Package: [2 Units] In Commercial Distribution |
| GS1 | 03573026596095 [Primary] |
| GS1 | 03573026611910 [Package] Contains: 03573026596095 Package: [50 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121446
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 | 2020-05-01 |
| Device Publish Date | 2020-04-23 |
Devices Manufactured by BIOMERIEUX , INC.
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| 00860007326912 - VITEK® REVEAL™ SEALER | 2024-10-17 The VITEK REVEAL SEALER provides the heat welding of the VITEK REVEAL SENSOR PANEL to the 96 well AST Drug Plate. |
| 03573026638900 - VITEK® REVEAL™ SENSOR PANEL | 2024-10-17 The VITEK REVEAL Reveal AST Assays are indicated for susceptibility testing of pathogenic bacteria |
| 03573026636357 - VITEK® 2 AST-N814 | 2023-12-14 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin |
| 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 |
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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