Integrated Cycler (220V)

GUDID 10816101025029

DIASORIN MOLECULAR LLC

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

• Primary Device ID: 10816101025029
• NIH Device Record Key: cbaae525-c3b0-4be7-8629-28b9fecce244
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrated Cycler (220V)
• Version Model Number: MOL1011
• 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
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816101025029 [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

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• 10816101027221 - Prothrombin (FII) HyBeacon Gen II Primer Pair: 2024-10-02
• 10816101027283 - Monkeypox Primer Pair: 2024-08-30
• 10816101027290 - Human GAPDH Endogenous Primer Pair: 2024-08-30
• 20816101027198 - Simplexa™ C. auris Direct: 2024-07-29
• 20816101027211 - Simplexa™ C. auris Positive Control Pack: 2024-07-29
• 20816101027235 - Simplexa™ C. auris Sample Prep Kit: 2024-07-29
• 10816101022240 - DxSelect™ Amber Sample Diluent: 2024-07-09