CLINITEK Atlas® Control+ Strips 5019
GUDID 00630414373201
Quality control for CLINITEK Atlas® and CLINITEK Novus® analyzers
Siemens Healthcare Diagnostics Inc.
Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control Multiple urine analyte IVD, control| Primary Device ID | 00630414373201 |
| NIH Device Record Key | 41e0995d-8729-472f-b774-0a6bdf415a58 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CLINITEK Atlas® Control+ Strips |
| Version Model Number | 10311124 |
| Catalog Number | 5019 |
| Company DUNS | 064608573 |
| Company Name | Siemens Healthcare Diagnostics Inc. |
| Device Count | 25 |
| 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 | 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414009315 [Unit of Use] |
| GS1 | 00630414373201 [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 |
Devices Manufactured by Siemens Healthcare Diagnostics Inc.
| 00630414313450 - Atellica CH Billirubin Calibrator (BILI CAL) | 2024-04-11 Atellica CH Bilirubin Calibrator (BILI CAL) |
| 00630414317427 - Clinistix UTI Test Strips | 2024-02-29 Test strips for urinary tract infection |
| 00630414626963 - ADVIA Centaur NT-PBNPII (PBNPII) | 2024-02-13 PBNPII - ADVIA Centaur - MCM Set |
| 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 [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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