| Primary Device ID | 03573026087357 |
| NIH Device Record Key | 52b44d64-c231-4ab2-a5e7-2f47ec20c60f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | API® OF |
| Version Model Number | API® OF |
| Company DUNS | 276816717 |
| Company Name | BIOMERIEUX SA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03573026087357 [Package] Contains: 03573026588670 Package: [10 Units] In Commercial Distribution |
| GS1 | 03573026588670 [Primary] |
| JSW | KIT, IDENTIFICATION, GLUCOSE NONFERMENTER |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-20 |
| Device Publish Date | 2020-04-10 |
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| 03573026633530 - ETEST® Imipenem Relebactam (IRPA) | 2025-07-01 ETEST is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1 |
| 03573026559823 - THxID™ BRAF | 2025-06-09 Software used in combination with the THxIDTM- BRAF assay (used to identify patients with melanoma whose tumors harbor the BRAF |
| 03573026637200 - VITEK® MS SOFTWARE v1.2 | 2025-05-07 The VITEK® MS Software is a computer application which supports the microbiology laboratory workflow for the VITEK® MS Systems |
| 03573026626891 - VIDAS® TBI (GFAP, UCH-L1) | 2024-11-08 VIDAS TBI (GFAP, UCH-L1) is an automated quantitative test to be used on VIDAS3. It is intended to be used as an aid in the eval |
| 03573026359096 - VITEK® MS-DS | 2024-04-30 The VITEK MS-DS target slides enable the identification of microorganisms according to the MALDI-TOF mass spectrometry method. |
| 03573026359119 - VITEK® MS | 2024-04-29 MALDI-Tof Mass Spectrometry system used for microbial identification |
| 03573026362843 - VITEK® MS FA | 2024-04-29 VITEK ® MS - FA is used to pretreat yeasts to facilitate their identification according to the MALDI - TOF method. It is used e |