DensiCHEK™ Plus Standards
GUDID 03573026222222
These are calibration standards for the DensiCHEK™ Plus instrument. This instrument is uses with the VITEK®2 to measure the optical density of bacterial suspensions.
BIOMERIEUX , INC.
Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable| Primary Device ID | 03573026222222 |
| NIH Device Record Key | 767654ff-bba5-4640-9a67-9abba5c76ba8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DensiCHEK™ Plus Standards |
| Version Model Number | 21255 |
| 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 | 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03573026222222 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K083536
FDA Product Code
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2021-05-10 |
| Device Publish Date | 2016-11-30 |
Devices Manufactured by BIOMERIEUX , INC.
| 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 |
| 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 [DensiCHEK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DENSICHEK 87263161 5259933 Live/Registered |
bioMerieux Inc. 2016-12-09 |
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