Emit® 2000 Carbamazepine Assay 4F229

GUDID 00842768023231

Emit® 2000 Carbamazepine Assay labeled with the Beckman Coulter® name

Siemens Healthcare Diagnostics Inc.

Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00842768023231
• NIH Device Record Key: ac05afed-8dad-4f93-8234-53f7312b9c70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Emit® 2000 Carbamazepine Assay
• Version Model Number: 10445311
• Catalog Number: 4F229
• Company DUNS: 005088112
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842768023231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010814

FDA Product Code

• KLT: ENZYME IMMUNOASSAY, CARBAMAZEPINE

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

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