ARCHITECT 06L3120

GUDID 00380740011222

Quinidine

ABBOTT LABORATORIES

Quinidine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00380740011222
• NIH Device Record Key: 5b0da8a8-7fc2-4b73-8765-dd9dd7fa477e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARCHITECT
• Version Model Number: 6L31-20
• Catalog Number: 06L3120
• Company DUNS: 079226220
• Company Name: ABBOTT LABORATORIES
• 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: 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
• 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

• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do no freeze reagents or expose reagents to temperatures above 32 degrees Celsius.
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740011222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052826

FDA Product Code

• LBZ: ENZYME IMMUNOASSAY, QUINIDINE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-06

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• 00380740169831: ARCHITECT cSystem eAssay CD-ROM Conventional Units/Alternate Units
• 00380740161323: ARCHITECT c Systems SI Units / Alternate Units MULTIGENT Assay Disk Version 7.00
• 00380740161316: ARCHITECT c Systems Conventional Units / Alternate Units MULTIGENT Assay Disk Version 7.00
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• 00380740158491: CRP Vario
• 00380740157067: ARCHITECT i1000sr System e-Assay CD ROM
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