CLINITEK Status®+ Analyzer 10379675

GUDID 00630414574639

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.

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• Primary Device ID: 00630414574639
• NIH Device Record Key: d5b9cb4a-afc0-45ef-9062-d2c33fc83550
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLINITEK Status®+ Analyzer
• Version Model Number: 10379675
• Catalog Number: 10379675
• 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
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: 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	00630414574639 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091216

FDA Product Code

• JFY: ENZYMATIC METHOD, CREATININE

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