| Primary Device ID | 04251204325642 |
| NIH Device Record Key | 9e28ac8d-8b5b-4d90-aef0-311cd0200f4e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | US IVD-Bruker Bacterial Test Standard, 5 Tubes |
| Version Model Number | 8604530 |
| Catalog Number | 8604530 |
| Company DUNS | 318387958 |
| Company Name | Bruker Daltonik GmbH |
| Device Count | 5 |
| 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 | 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 |
| Phone | +1(877)442-2231 |
| ms.support.us@bruker.com |
| Special Storage Condition, Specify | Between 0 and 0 *Max 8hr working time unrefridgerated. |
| Special Storage Condition, Specify | Between 0 and 0 *Min shelf life 12 months. Min shelf life 5 months frozen, reconstituted. |
| Storage Environment Temperature | Between -18 Degrees Celsius and -18 Degrees Celsius |
| Handling Environment Temperature | Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04251204325642 [Primary] |
| GS1 | 04251204325758 [Unit of Use] |
| PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-25 |
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