| Primary Device ID | 00857573006300 |
| NIH Device Record Key | b6fbac9f-03b3-4f36-bd2a-cb262c7fc4cd |
| Commercial Distribution Discontinuation | 2019-12-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Gram-Negative Blood Culture (BC-GN) Utility Tray |
| Version Model Number | 20-011-021 |
| Company DUNS | 164757242 |
| Company Name | NANOSPHERE, 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 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 and -20 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840487101698 [Primary] |
| GS1 | 00857573006300 [Primary] |
| PEN | Gram-Negative Bacteria And Associated Resistance Markers |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-06 |
| Device Publish Date | 2016-09-23 |
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