IMMULITE® 2000 Systems TT4 Total T4 L2KT42

GUDID 00630414972992

T4 Total - IMMULITE - RGT - 200 Tests

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00630414972992
• NIH Device Record Key: 150dd4b0-df91-4b8f-b9e6-1cba22714cbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMULITE® 2000 Systems TT4 Total T4
• Version Model Number: 10381685
• Catalog Number: L2KT42
• Company DUNS: 296822794
• Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
• 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: 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414972992 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910261

FDA Product Code

• KLI: Enzyme immunoassay, non-radiolabeled, total thyroxine

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 [IMMULITE® 2000 Systems TT4 Total T4]

• 00630414972992: T4 Total - IMMULITE - RGT - 200 Tests
• 00630414966038: T4 Total - IMMULITE - RGT - 600 Tests