Primary Device ID | 04015630036820 |
NIH Device Record Key | dd8a304e-6b5d-4db1-b5ae-1148908a92c0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ISE Calibrator indirect / urine |
Version Model Number | 4838149001 |
Catalog Number | 4838149001 |
Company DUNS | 315028860 |
Company Name | Roche Diagnostics GmbH |
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 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04015630036820 [Primary] |
JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-12-21 |
Device Publish Date | 2016-09-20 |
07613336228623 - navify POC Operations | 2024-05-08 |
07613336224816 - ONLINE TDM Methotrexate | 2024-04-02 |
07613336224823 - ONLINE TDM Methotrexate | 2024-04-02 |
07613336224830 - MTX Calibrator | 2024-04-02 |
07613336217689 - Elecsys ProBNP II | 2024-02-27 |
04015630929702 - cobas Elecsys AntiTPO | 2024-02-16 |
04015630939626 - Elecsys Anti-TPO | 2024-02-16 |
04015630899548 - Elecsys CalSet TUptake | 2024-02-05 |