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

• 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

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• 00630414579108 - ADVIA Centaur ELF Quality Control: 2025-08-18 Enhanced Liver Fibrosis (ELF) QC Kit - ADVIA Centaur - CLT 3 x 3 x 2.0 mL
• 00630414598901 - Atellica IM Enhanced Liver Fibrosis Quality Control (ELF QC): 2025-08-18 Enhanced Liver Fibrosis (ELF) QC Kit - Atellica IM - CLT 3 x 3 x 2.0 mL
• 00630414632926 - Atellica IM DHEAS2 100T KIT: 2025-03-28 Atellica IM DHEASII 100T KIT
• 00630414632940 - Atellica IM DHEAS2 MCM SET: 2025-03-28 Atellica IM DHEASII MCM SET
• 00630414321486 - Atellica IM DHEAS2 (REF) 500T: 2025-03-28 Atellica IM DHEAS2 (REF) 500T Atellica IM-REF Reagent (REF RGT)
• 00630414650579 - Atellica IM 1300 Analyzer: 2025-03-24 Recertified Atellica IM 1300 Analyzer