ARCHITECT 06L9620

GUDID 00380740011529

Phencyclidine

ABBOTT LABORATORIES

Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00380740011529
• NIH Device Record Key: c7fff992-a00d-4a5e-996a-184c790d50e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARCHITECT
• Version Model Number: 6L96-20
• Catalog Number: 06L9620
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze reagents or expose them to temperatures above 32 degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze reagents or expose them to temperatures above 32 degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze reagents or expose them to temperatures above 32 degrees Celsius.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze reagents or expose them to temperatures above 32 degrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze reagents or expose them to temperatures above 32 degrees Celsius.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze reagents or expose them to temperatures above 32 degrees Celsius.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze reagents or expose them to temperatures above 32 degrees Celsius.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze reagents or expose them to temperatures above 32 degrees Celsius.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze reagents or expose them to temperatures above 32 degrees Celsius.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze reagents or expose them to temperatures above 32 degrees Celsius.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze reagents or expose them to temperatures above 32 degrees Celsius.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze reagents or expose them to temperatures above 32 degrees Celsius.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze reagents or expose them to temperatures above 32 degrees Celsius.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze reagents or expose them to temperatures above 32 degrees Celsius.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze reagents or expose them to temperatures above 32 degrees Celsius.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze reagents or expose them to temperatures above 32 degrees Celsius.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze reagents or expose them to temperatures above 32 degrees Celsius.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 0 and 29 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740011529 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935320

FDA Product Code

• LCM: Enzyme immunoassay, phencyclidine

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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• 00380740158507: CRP Vario
• 00380740158491: CRP Vario
• 00380740157067: ARCHITECT i1000sr System e-Assay CD ROM
• 00380740157050: ARCHITECT i System e-Assay CD-ROM
• 00380740156909: ARCHITECT cSystem Theophylline SI Units e-Assay CD-ROM v1.0
• 00380740156893: ARCHITECT cSystem Theophylline Conventional Units e-Assay CD-ROM v1.0
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• 00380740152147: ARCHITECT cSystem SI Units e-Assay CD ROM V15.0
• 00380740152130: ARCHITECT cSystem Conv Units e-Assay CD ROM V15.0
• 00380740150150: ARCHITECT i1000SR System e-Assay CD-ROM
• 00380740150143: ARCHITECT i System e-Assay CD-ROM
• 00380740146689: ARCHITECT UIBC-L SI Units e-Assay CD ROM
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• 00380740145194: ARCHITECT TBili Conv Units e-Assay CD-ROM
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• 00380740138738: ARCHITECT ROMA
• 00380740138615: ARCHITECT i1000SR System e-Assay CD-ROM
• 00380740138608: ARCHITECT i System e-Assay CD-ROM
• 00380740137045: UIBC
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• 00380740117061: ARCHITECT c16000 REFURBISHED PROCESSING MODULE
• 00380740116095: ARCHITECT c4000 PROCESSING MODULE INTEGRATED
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• 00380740102708: Phenytoin
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