| Primary Device ID | 03573026619268 |
| NIH Device Record Key | c3cadde2-7540-48db-b672-862f0097f1c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VITEK 2 ® AST-YS09 |
| Version Model Number | VITEK®2 AST-YS09 |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03573026619268 [Package] Contains: 03573026619350 Package: [20 Units] In Commercial Distribution |
| GS1 | 03573026619350 [Primary] |
| NGZ | SUSCEPTIBILITY TEST PLATE, ANTIFUNGAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-15 |
| Device Publish Date | 2019-04-05 |
| 03573026641337 - VITEK® 2 AST-N815 | 2024-11-21 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin |
| 00860007326905 - VITEK® REVEAL™ | 2024-10-17 The VITEK REVEAL Instrument is a benchtop instrument that processes up to four AST tests . Installation and operating details f |
| 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 |