ATELLICA HA1C_E HIGH VOLUME BOTTLE KIT 11597087

GUDID 00630414304304

HA1C_E HIGH VOLUME BOTTLE KIT ATELLICA CH (5 BOTTLES)

Siemens Healthcare Diagnostics Inc.

Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable Assay container IVD, reusable

• Primary Device ID: 00630414304304
• NIH Device Record Key: ed04185e-272d-444a-a401-2b9074feca7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATELLICA HA1C_E HIGH VOLUME BOTTLE KIT
• Version Model Number: 11597087
• Catalog Number: 11597087
• Company DUNS: 064608573
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: 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 *without restrictions
• Special Storage Condition, Specify: Between 0 and 0 *without restrictions
• Special Storage Condition, Specify: Between 0 and 0 *without restrictions
• Special Storage Condition, Specify: Between 0 and 0 *without restrictions
• Special Storage Condition, Specify: Between 0 and 0 *without restrictions
• Special Storage Condition, Specify: Between 0 and 0 *without restrictions

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414304304 [Primary]

FDA Product Code

• JJE: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

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: 2022-05-27
• Device Publish Date: 2022-05-19

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

• 00630414305028 - Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2): 2024-06-19 Atellica CH High Sensitivity C-Reactive Protein (hCRP2) Reagent
• 00630414624488 - ADVIA Centaur TSH3-Ultra II: 2024-05-30 TSH3-ULII ADVIA Centaur - RGT 500T
• 00630414624501 - ADVIA Centaur TSH3-Ultra II: 2024-05-30 TSH3-ULII ADVIA Centaur - RGT (REF) 2500T
• 00630414624518 - Atellica IM TSH3-Ultra II: 2024-05-30 TSH3-ULII Atellica IM - RGT 110T
• 00630414624525 - Atellica IM TSH3-Ultra II: 2024-05-30 TSH3-ULII Atellica IM – RGT 550T
• 00630414624532 - Atellica IM TSH3ULII MCM set: 2024-05-30 TSH3-ULII Atellica IM - Consumable MCM Set
• 00630414624693 - Atellica IM TSH3-Ultra II: 2024-05-30 TSH3-ULII Atellica IM - RGT (REF) 2750T
• 00630414624709 - ADVIA Centaur TSH3ULII MCM SET: 2024-05-30 TSH3-ULII ADVIA Centaur - Consumable MCM Set