Integrated Cyler (110V)

GUDID 10816101025005

DIASORIN MOLECULAR LLC

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory

• Primary Device ID: 10816101025005
• NIH Device Record Key: 6047fe36-d67f-4666-b9f3-31d4957b6138
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrated Cyler (110V)
• Version Model Number: MOL1001
• Company DUNS: 080271715
• Company Name: DIASORIN MOLECULAR LLC
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816101025005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102314

FDA Product Code

• OOI: Real Time Nucleic Acid Amplification System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-07-07
• Device Publish Date: 2016-09-24

Devices Manufactured by DIASORIN MOLECULAR LLC

• 20816101027143 - Simplexa COVID-19 & Flu A/B Direct: 2023-07-03
• 20816101025835 - Simplexa Congenital CMV Direct: 2023-06-26
• 20816101025842 - Simplexa Congenital CMV Positive Control Pack: 2023-06-26
• 20816101027020 - Simplexa COVID-19 Direct: 2023-06-26
• 20816101027037 - Simplexa COVID-19 Positive Control Pack: 2023-06-26
• 20816101027150 - Simplexa COVID-19 & Flu A/B Positive Control Pack: 2023-06-26
• 10816101022295 - DxSelect™ - Substrate Reagent: 2023-06-02
• 10816101025111 - Universal Disc Cover Tape: 2021-12-08