Simplexa Congenital CMV Direct MOL2255

GUDID 20816101025835

DIASORIN MOLECULAR LLC

Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 20816101025835
• NIH Device Record Key: 4b71e27c-e41f-447d-b5b9-5d4191d20058
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplexa Congenital CMV Direct
• Version Model Number: MOL2255
• Catalog Number: MOL2255
• 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: 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: 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
• 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
• Phone: 562-240-6500
• Email: TS.molecular@diasorin.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	20816101025835 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202755

FDA Product Code

• QDZ: Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-26
• Device Publish Date: 2023-06-16

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• 10816101022240 - DxSelect™ Amber Sample Diluent: 2024-07-09
• 10816101022325 - West Nile Virus IgG DxSelect™ IgG Cutoff Calibrator: 2024-07-08
• 10816101022332 - West Nile Virus IgG Positive Control DxSelect™ - IgG Positive Control: 2024-07-08