Clinitek Atlas® Rinse Additiive 5007A
GUDID 00630414372464
Rinse additive, an in vitro diagnostics device for use on the CLINITEK Atlas® automated urine chemistry system
Siemens Healthcare Diagnostics Inc.
Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD| Primary Device ID | 00630414372464 |
| NIH Device Record Key | e7778c74-aa15-4312-ab95-4bbd41cfcef0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clinitek Atlas® Rinse Additiive |
| Version Model Number | 10311113 |
| Catalog Number | 5007A |
| Company DUNS | 064608573 |
| Company Name | Siemens Healthcare Diagnostics Inc. |
| Device Count | 4 |
| 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 | |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414009308 [Unit of Use] |
| GS1 | 00630414372464 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K932674
FDA Product Code
| KQO | AUTOMATED URINALYSIS SYSTEM |
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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| 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 [Clinitek Atlas]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLINITEK ATLAS 75168581 2086027 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1996-09-19 |
 CLINITEK ATLAS 75168547 2086025 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1996-09-19 |
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