ADVIA® Chemistry GENT_2 Gentamicin_2 Reagents 10377507
GUDID 00630414561943
Gentamicin - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)| Primary Device ID | 00630414561943 |
| NIH Device Record Key | 575b0afc-4baf-4bc4-942a-5d2cd646e286 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ADVIA® Chemistry GENT_2 Gentamicin_2 Reagents |
| Version Model Number | 10377507 |
| Catalog Number | 10377507 |
| Company DUNS | 064608573 |
| Company Name | Siemens Healthcare Diagnostics 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 | 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze, Avoid prolonged exposure to temperatures above 32°C |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414561943 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K962519
FDA Product Code
| LCD | ENZYME IMMUNOASSAY, GENTAMICIN |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
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| 00630414626970 - ATELLICA IM NT-PBNPII (PBNPII) | 2024-02-13 PBNPII - ATELLICA IM - MCM Set |
| 00630414284927 - ADVIA Centaur PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 100T |
| 00630414284934 - ADVIA Centaur PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 500T |
| 00630414284941 - Atellica IM PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - Atellica IM - RGT - 100T |
| 00630414284958 - Atellica IM PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - Atellica IM - RGT - 500T |
Trademark Results [ADVIA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADVIA 86019036 4590109 Live/Registered |
First Community Federal Credit Union 2013-07-24 |
 ADVIA 75167452 2162740 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1996-09-17 |
 ADVIA 75167451 2177388 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1996-09-17 |
 ADVIA 74647180 not registered Dead/Abandoned |
ALLERGAN, INC. 1995-03-15 |
 ADVIA 74246810 1838573 Dead/Cancelled |
Alacritous Inc. 1992-02-18 |
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