DV/DM COV2G/CV2G POS/NEG CTRL KC873

GUDID 00630414298405

DV/DM COV2G/CV2G POS/NEG CTRL

Siemens Healthcare Diagnostics Inc.

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

• Primary Device ID: 00630414298405
• NIH Device Record Key: e5fe7f12-790f-4a78-ab26-8e6a357e1079
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DV/DM COV2G/CV2G POS/NEG CTRL
• Version Model Number: 11417773
• Catalog Number: KC873
• Company DUNS: 005088112
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 6
• 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: 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)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414298405 [Unit of Use]
GS1	00630414607054 [Primary]

FDA Product Code

• QCH: Assayed quality control material for clinical microbiology assays

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: 2021-02-01
• Device Publish Date: 2021-01-22

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