Atellica CH OXY 11097541

GUDID 00630414238098

Oxycodone (OXY) Atellica CH - RGT 1520T

Siemens Healthcare Diagnostics Inc.

Oxycodone IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00630414238098
• NIH Device Record Key: b3089f3e-128b-4020-976d-89b5725a3b58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atellica CH OXY
• Version Model Number: 11097541
• Catalog Number: 11097541
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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: 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

• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store upright; Do not freeze
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414238098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172910

FDA Product Code

• DJG: Enzyme immunoassay, opiates

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-09
• Device Publish Date: 2018-09-24

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