ABBOTT PRISM 03R9702

GUDID 00380740138400

ABBOTT PRISM Director Version 2.1

ABBOTT LABORATORIES

Laboratory instrument/analyser application software IVD

• Primary Device ID: 00380740138400
• NIH Device Record Key: babda526-35ea-4ec0-86dc-1351a95c2b46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABBOTT PRISM
• Version Model Number: 3R97-02
• Catalog Number: 03R9702
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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(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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740138400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK130020

FDA Product Code

• MTQ: Software, blood virus applications

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: 2016-09-09

On-Brand Devices [ABBOTT PRISM]

• 00380740138400: ABBOTT PRISM Director Version 2.1
• 00380740138394: ABBOTT PRISM Director Version 2.0
• 00380740063016: ABBOTT PRISM HTLV-I/HTLV-II Assay Kit
• 00380740062996: ABBOTT PRISM HCV Assay Kit
• 00380740062989: ABBOTT PRISM HBsAg Assay Kit
• 00380740062972: ABBOTT PRISM HBsAg Confirmatory Assay Kit
• 00380740062965: ABBOTT PRISM HBcore Assay Kit
• 00380740062958: ABBOTT PRISM HIV O Plus Assay Kit
• 00380740062941: ABBOTT PRISM Chagas Assay Kit
• 00380740059972: ABBOTT PRISM HTLV-I/HTLV-II Wash Kit
• 00380740059965: ABBOTT PRISM HCV Wash Kit
• 00380740059958: ABBOTT PRISM HBsAg Wash Kit
• 00380740059941: ABBOTT PRISM HBcore Wash Kit
• 00380740059934: ABBOTT PRISM HIV O Plus Wash Kit
• 00380740059927: ABBOTT PRISM Chagas Wash Kit
• 00380740050375: ABBOTT PRISM Purge Concentrate
• 00380740039219: ABBOTT PRISM Positive Run Control Kit
• 00380740038403: ABBOTT PRISM Run Control Kit
• 00380740038380: ABBOTT PRISM Chagas Run Control Kit
• 00380740038373: ABBOTT PRISM Activator Line Treatment
• 00380740030445: ABBOTT PRISM Activator Concentrate
• 00380740027056: ABBOTT PRISM Prime/Purge Accessories
• 00380740027001: ABBOTT PRISM Activator Diluent
• 00380740012403: ABBOTT PRISM SAMPLE CUPS
• 00380740011604: ABBOTT PRISM Line Cleaner
• 00380740008574: ABBOTT PRISM NEXT MAIN INSTRUMENT SIX CHANNEL
• 00380740008420: ABBOTT PRISM NEXT MAIN INSTRUMENT SIX CHANNEL
• 00380740007911: ABBOTT PRISM Pipette Tips
• 00380740007904: ABBOTT PRISM Reaction Trays