ARCHITECT 06S6010

GUDID 00380740193744

AdviseDx SARS-CoV-2 IgG II Control Kit

Abbott Ireland Diagnostics

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: 00380740193744
• NIH Device Record Key: 42547e7c-5ece-4a05-9709-006e2fa0f336
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARCHITECT
• Version Model Number: 06S6010
• Catalog Number: 06S6010
• Company DUNS: 985307301
• Company Name: Abbott Ireland Diagnostics
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx
• Phone: +1(877)422-2688
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store below -20 CEL until first use
• Handling Environment Temperature: Between 0 and 0 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740193744 [Primary]

FDA Product Code

• QKO: Reagent, coronavirus serological

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: 2021-04-14
• Device Publish Date: 2021-04-06

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