IMMULITE® 2000 Systems CEA L2KCE6

GUDID 00630414961125

CEA - IMMULITE - RGT - 600 Tests

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00630414961125
• NIH Device Record Key: a2d330ce-76aa-4e40-a761-1202555f6aee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMULITE® 2000 Systems CEA
• Version Model Number: 10380995
• Catalog Number: L2KCE6
• 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	00630414961125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980855

FDA Product Code

• DHX: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

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 CEA]

• 00630414961125: CEA - IMMULITE - RGT - 600 Tests
• 00630414961118: CEA - IMMULITE - RGT - 200 Tests