Atellica IM EPO 10733006

GUDID 00630414245775

Erythropoietin (EPO) - Atellica IM - RGT 100T

Siemens Healthcare Diagnostics Inc.

Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00630414245775
• NIH Device Record Key: 41092e95-e22e-4d11-a814-12a21694f3f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atellica IM EPO
• Version Model Number: 10733006
• Catalog Number: 10733006
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	00630414245775 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183088

FDA Product Code

• GGT: ASSAY, ERYTHROPOIETIN

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: 2019-11-26
• Device Publish Date: 2019-11-18

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