CLINITEK Status®+ Analyzer 10379677
GUDID 00630414572314
The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following inurine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).
Siemens Healthcare Diagnostics Inc.
Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care Urine analyser IVD, point-of-care| Primary Device ID | 00630414572314 |
| NIH Device Record Key | cd3525c1-ca59-4a57-a716-e6e03a02dc51 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CLINITEK Status®+ Analyzer |
| Version Model Number | 10379677 |
| Catalog Number | 10379677 |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Max 95% RH at 45'c |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414572314 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K091216
FDA Product Code
| CDM | DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) |
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 |
On-Brand Devices [CLINITEK Status®+ Analyzer]
| 00630414574639 | The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designe |
| 00630414572314 | The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designe |
Trademark Results [CLINITEK Status]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLINITEK STATUS 78105457 2946633 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 2002-01-29 |
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