RealTime 08L21-01

GUDID 00884999034266

Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM, Version 1.0

ABBOTT MOLECULAR INC.

Laboratory instrument/analyser application software IVD

• Primary Device ID: 00884999034266
• NIH Device Record Key: 0bf57a52-dde5-431d-967d-65df496ec6b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RealTime
• Version Model Number: 08L21-01
• Catalog Number: 08L21-01
• Company DUNS: 878263359
• Company Name: ABBOTT MOLECULAR INC.
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• 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(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884999034266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P120012

FDA Product Code

• OBF: Assay, genotyping, hepatitis c virus

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: 2014-11-20

On-Brand Devices [RealTime]

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• 00884999047792: Abbott RealTime IDH1m2000rt Application CD-ROM
• 00884999047358: Abbott RealTime IDH1 Amplification Reagent Kit
• 00884999047341: Abbott RealTime IDH1 Control Kit
• 00884999047297: Abbott RealTime CMV m2000 System Combined Application CD-ROM
• 00884999047051: Abbott RealTime IDH2 Control Kit
• 00884999047044: Abbott RealTime IDH2 Amplification Reagent Kit
• 00884999047037: Abbott RealTime IDH2 m2000rt Application CD-ROM
• 00884999046603: Abbott Proteinase K Recombinant, PCR Grade
• 00884999045798: Abbott RealTime CMV Amplification Reagent Kit
• 00884999045781: Abbott RealTime CMV Control Kit
• 00884999045774: Abbott RealTime CMV Calibrator Kit
• 00884999042704: Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM
• 00884999042681: Abbott RealTime HCV m2000 System Combined Application CD-ROM
• 00884999042667: Abbott RealTime HBV m2000 System Combined Application CD-ROM
• 00884999042513: Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM
• 00884999038462: Abbott RealTime HBV Amplification Reagent Kit
• 00884999037762: Abbott RealTime HBV m2000 System Combined Application CD-ROM, Version 3.0
• 00884999037656: Abbott RealTime HCV m2000 System Combined Application CD-ROM, Version 3.0
• 00884999037472: Uracil-N-Glycosylase (UNG)
• 00884999037434: Abbott RealTime HCV Including Uracil-N-Glycosylase (UNG)
• 00884999037427: Abbott RealTime HIV-1 Amplification Extended Use Including Uracil-N-Glycosylase (UNG)
• 00884999037410: Abbott RealTime CT/NG Amplification Reagent Extended Use Including Uracil-N-Glycosylase (UNG)
• 00884999037304: Abbott RealTime HIV-1 Amplification Reagent Extended Use
• 00884999037298: Abbott RealTime CT/NG Amplification Reagent Extended Use with Pierceable Caps
• 00884999037168: Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM, Version 6.0
• 00884999037113: Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application CD-ROM, Version
• 00884999036444: Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV Genotype II Assay
• 00884999036147: Abbott RealTime HCV Genotype II Control Kit
• 00884999036130: Abbott RealTime HCV Genotype II Amplification Reagent Kit
• 00884999034266: Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM, Version 1.0
• 00884999031142: Abbott RealTime CT/NG Amplification Reagent Kit
• 00884999031128: Abbott RealTime CT/NG Control Kit
• 00884999023949: Abbott RealTime HIV-1 Amplification Reagent Kit
• 00884999023932: Abbott RealTime HIV-1 Control Kit
• 00884999023925: Abbott RealTime HIV-1 Calibrator Kit
• 00884999023918: Abbott RealTime HIV-1 Amplification Including Uracil-N-Glycosylase (UNG) for use in conjunction
• 00884999006584: AM Transport Cap Standard
• 00884999003071: Abbott RealTime HBV Amplification Reagent Kit
• 00884999003064: Abbott RealTime HBV Control Kit
• 00884999003057: Abbott RealTime HBV Calibrator Kit
• 00884999000728: Abbott RealTime HCV Amplification Reagent Kit
• 00884999000711: Abbott RealTime HCV Control Kit
• 00884999000704: Abbott RealTime HCV Calibrator Kit
• 00884999000698: Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV (List Number 1N30-90)
• 00884999049109: Abbott RealTime SARS-CoV-2 Amplification Reagent Kit
• 00884999049086: Abbott RealTime SARS-CoV-2 Control Kit
• 00884999049055: Abbott RealTime SARS-CoV-2 Application CD-ROM
• 30884999049131: Abbott Universal Collection Kit
• 00884999047068: Abbott RealTime ZIKA Application CD-ROM