ARCHITECT 02K9101

GUDID 00380740003555

ARCHITECT CA19-9XR Calibrators

ABBOTT LABORATORIES

Cancer antigen 19-9 (CA19-9) IVD, calibrator

• Primary Device ID: 00380740003555
• NIH Device Record Key: 78f3630e-480d-4a81-afe6-a6fd73742a96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARCHITECT
• Version Model Number: 2K91-01
• Catalog Number: 02K9101
• 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
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740003555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052000

FDA Product Code

• JIT: CALIBRATOR, SECONDARY

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

On-Brand Devices [ARCHITECT]

• 00380740169978: Architect c8000 CRP1 eAssay CD-ROM
• 00380740169848: Architect cSystem e-Assay CD-ROM SI-Units/Alternate Units
• 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
• 00380740159429: ARCHITECT i1000SR System e-Assay CD-ROM
• 00380740159412: ARCHITECT i System e-Assay CD-ROM
• 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
• 00380740156886: ARCHITECT cSystem Phenytoin SI Units e-Assay CD-ROM v1.0
• 00380740156879: ARCHITECT cSystem Phenytoin Conventional Units e-Assay CD-ROM v1.0
• 00380740153441: ARCHITECT i1000SR e-Assay CD-ROM
• 00380740153434: ARCHITECT i System e-Assay CD-ROM
• 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
• 00380740146672: ARCHITECT UIBC-L Conv Units e-Assay CD ROM
• 00380740145194: ARCHITECT TBili Conv Units e-Assay CD-ROM
• 00380740145156: ARCHITECT TBili SI Units e- Assay CD-ROM
• 00380740139537: ARCHITECT i1000SR System e-Assay CDROM
• 00380740139520: ARCHITECT i System e-Assay CD-ROM
• 00380740138738: ARCHITECT ROMA
• 00380740138615: ARCHITECT i1000SR System e-Assay CD-ROM
• 00380740138608: ARCHITECT i System e-Assay CD-ROM
• 00380740137045: UIBC
• 00380740121075: Lactic Acid
• 00380740117061: ARCHITECT c16000 REFURBISHED PROCESSING MODULE
• 00380740116095: ARCHITECT c4000 PROCESSING MODULE INTEGRATED
• 00380740116057: ARCHITECT c4000 PROCESSING MODULE
• 00380740116019: ARCHITECT i1000SR INTEGRATED MODULE
• 00380740115289: ABBOTT ARCHITECT Reaction Vessels
• 00380740112196: Detergent B
• 00380740105464: ARCHITECT CA19-9XR Reagent Kit
• 00380740103163: ARCHITECT c8000 REFURBISHED PROCESSING MODULE
• 00380740103156: ARCHITECT i1000SR REFURBISHED PROCESSING MODULE
• 00380740102746: Hemoglobin A1c
• 00380740102739: Hemoglobin A1c Controls
• 00380740102722: Hemoglobin A1c Calibrators
• 00380740102715: Theophylline
• 00380740102708: Phenytoin
• 00380740102692: Phenobarbital
• 00380740102685: Carbamazepine
• 00380740102678: Lipid Multiconstituent Calibrator
• 00380740101220: TDM Multiconstituent Calibrator