Atellica IM CA 15-3 10995486

GUDID 00630414598130

CA 15-3 Atellica IM - RGT 500T

Siemens Healthcare Diagnostics Inc.

Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00630414598130
• NIH Device Record Key: 311c620e-342b-4865-bab8-3e3ac8d05330
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atellica IM CA 15-3
• Version Model Number: 10995486
• Catalog Number: 10995486
• Company DUNS: 064608573
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 5
• 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: 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
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• Phone: +1(877)229-3711
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• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
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• Phone: +1(877)229-3711
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• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
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• Phone: +1(877)229-3711
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• Phone: +1(877)229-3711
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• Phone: +1(877)229-3711
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• Phone: +1(877)229-3711
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• 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
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• Phone: +1(877)229-3711
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• Phone: +1(877)229-3711
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• Phone: +1(877)229-3711
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• Phone: +1(877)229-3711
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• 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
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• Phone: +1(877)229-3711
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• Phone: +1(877)229-3711
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• 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
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• 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
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• Phone: +1(877)229-3711
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• Phone: +1(877)229-3711
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• Phone: +1(877)229-3711
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• Phone: +1(877)229-3711
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• 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
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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright, Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414007397 [Unit of Use]
GS1	00630414598130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012357

FDA Product Code

• MOI: SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

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: 2018-02-06

On-Brand Devices [Atellica IM CA 15-3]

• 00630414598130: CA 15-3 Atellica IM - RGT 500T
• 00630414598123: CA 15-3 Atellica IM - RGT 100T
• 00630414294063: CA 15-3 Atellica IM - RGT 500T