Stratus® CS STAT Fluorometric Analyzer Rotors CROTOR

GUDID 00842768004674

Stratus® CS STAT Fluorometric Analyzer Rotor is an in vitro diagnostics device which is intended to be used on the Stratus® CS analyzer.

Siemens Healthcare Diagnostics Inc.

Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle Centrifuge rotor, fixed angle

• Primary Device ID: 00842768004674
• NIH Device Record Key: 9740cf8e-8dc1-4ee5-bb1f-f0e4c22fc1ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stratus® CS STAT Fluorometric Analyzer Rotors
• Version Model Number: 10445088
• Catalog Number: CROTOR
• Company DUNS: 005088112
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 100
• 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(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: 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
• 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	00630414009988 [Unit of Use]
GS1	00842768004674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984067

FDA Product Code

• JHX: FLUOROMETRIC METHOD, CPK OR ISOENZYMES

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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