IMMULITE® 2000 Systems E2 Estradiol L2KE22(D)

GUDID 00630414947907

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00630414947907
• NIH Device Record Key: 93c6ac58-ce49-43da-bbf8-fef091818c7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMULITE® 2000 Systems E2 Estradiol
• Version Model Number: 10702833
• Catalog Number: L2KE22(D)
• 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	00630414947907 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932926

FDA Product Code

• CHP: RADIOIMMUNOASSAY, ESTRADIOL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-02
• Device Publish Date: 2020-09-24

On-Brand Devices [IMMULITE® 2000 Systems E2 Estradiol]

• 00630414947914: 10702834
• 00630414947907: 10702833