IMMULITE® Systems PTH Calibration Verification Material Intact PTH LPPCVM

GUDID 00630414979410

PTH Intact CVM - IMMULITE - CONS

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Parathyroid hormone (PTH) IVD, control

• Primary Device ID: 00630414979410
• NIH Device Record Key: ceed7bc2-afa4-42d5-83fb-bd35f31bcf77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMULITE® Systems PTH Calibration Verification Material Intact PTH
• Version Model Number: 10388105
• Catalog Number: LPPCVM
• 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: 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 -25 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414979410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020217

FDA Product Code

• JJX: SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-09-24

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